Lediga jobb Procella Therapeutics AB i Stockholm

SmartCella is a world-leading biotech company pioneering the future of targeted therapies through delivery solutions and advanced therapy development. Founded in 2014, the company is built on globally renowned science and research from Karolinska Institutet in Sweden. SmartCella combines novel delivery platforms, such as the Extroducer (an endovascular delivery device that enables direct injection to hard-to-reach organs and tumors), with cutting-edge development and manufacturing of cell-mediated therapies. The company operates in two business segments: Targeted Deliveries and Regenerative Medicines.
To our Targeted Deliveries segment, the business unit SmartWise Sweden AB, are we now seeking a QA Manager, Production to join our growing Quality & Regulatory Affairs (QARA) team.
About the position
We are on an exciting path of growth and innovation and are now looking for a detail-oriented and organized professional with knowhow and experience in medical device development and production.
In this role, your main responsibility is to ensure quality assurance and regulatory compliance within our planned production facility and cleanroom. You will play a key part in establishing and maintaining standards and work instructions for compliant and efficient production processes that meet medical device standards and regulatory requirements.
Your scope will cover the full range of in-house manufacturing QA activities — from batch record release, deviation and CAPA management, and validation oversight, to providing strategic quality input on equipment, systems, and post-launch changes. You will also collaborate closely with suppliers and contract manufacturers to ensure consistent quality performance throughout the supply chain.
In addition to your primary responsibilities, you will assist the QARA team in activities related to the development and maintenance of the quality management system, provide QA/RA support for development projects, and contribute to regulatory activities, including authority reporting and submissions.
Your responsibilities will Include, but not be limited to
- Work with Production to enhance understanding and application of quality standards and promote proactive quality practices.
- Support Production to establish standards and work instructions for compliant and efficient production processes.
- Integrate risk management into Production by conducting risk assessments and utilizing pFMEA outputs to guide the quality strategy.
- Lead validation activities for manufacturing processes, equipment, system, and product changes to ensure compliance with quality and regulatory standards.
- Review and release production batch records.
- Coordinate with Production to manage supplier quality performance and incoming inspection effectiveness.
- Lead and collaborate with Production, Supply Chain, Sales and CMOs to investigate deviations and CAPAs.

- Analyse trends within Production to drive continuous improvement.
- Act as Quality Regulatory representative in product development projects, including risk management activities.
- Coordinate continuous transitions from Development to Production, providing feedback and implementation assistance.
- Assist Clinical Affairs in work related to clinical trials.
- Assist the QA manager in development of the QMS and QA related processes and activities; compliant handling, audit, change control, management review, training etc.
- Assist Regulatory Affairs to develop and manage regulatory strategy for Targeted Delivery’s portfolio of Class IIb and Class III products.
- Assist Regulatory Affairs for putting together technical files and submission dossier.
Who we are looking for
We are seeking an experienced and hands-on Quality professional with a strong background in medical device development and manufacturing. You thrive in a dynamic environment where structure and innovation must coexist, and you have a pragmatic, solution-oriented approach to quality management.
You combine a solid understanding of ISO 13485 and relevant regulatory frameworks (such as MDR and FDA 21 CFR 820) with practical experience implementing and maintaining compliant production processes. You are comfortable working across fields, from R&D and Development to Production and Supply Chain, from quality assurance to regulatory affairs, and you know how to translate quality requirements into efficient operational practices.
To succeed in this role, you should have:
• University degree in engineering, life sciences, or a related technical field.
• Strong knowledge of medical device QMS principles, originating from ISO13485, 21 CFR Part 820 and MDR. Previous experience from class III devices is an advantage.
• >3 years of experience in quality assurance in the medical device industry, with documented experience from manufacturing. Cleanroom experience is an advantage.
• Proven ability to interpret and apply regulatory requirements to practical Production challenges.
• Excellent communication skills and the confidence to influence and support cross-functional teams.
• A proactive mindset, attention to detail, and the ability to balance compliance with operational efficiency.
If you’re motivated by building quality into every step of production and want to contribute to bringing innovative medical technologies to market, SmartWise offers a role with real impact and growth potential. Fluency in English is mandatory, Swedish highly preferred.
Interested? Submit your application today! We will review applications on an ongoing basis and hope to fill the position as soon as possible.
The SmartCella group consist of SmartCella Holding AB, ProCella Therapeutics AB, SmartWise AB and SmartCella Solutions AB with a total of 82 employees from more than 20 nationalities. Visa mindre

SmartCella is a world-leading biotech company pioneering the future of targeted therapies through delivery solutions and advanced therapy development. Founded in 2014, the company is built on globally renowned science and research from Karolinska Institutet in Sweden. SmartCella combines novel delivery platforms, such as the Extroducer (an endovascular delivery device that enables direct injection to hard-to-reach organs and tumors), with cutting-edge development and manufacturing of cell-mediated therapies. The company operates in two business segments: Targeted Deliveries and Regenerative Medicines.
To our Targeted Deliveries segment, the business unit SmartWise Sweden AB, are we now seeking a Clinical Reasearch Associate/Clinical Trial Assistant to join our growing team. About The Position
As Clinical Research Associate (CRA) / Clinical Trial Assistant (CTA) you will play an integral role in the planning, coordination, and execution of medical device clinical trials, including studies with combination product components (drug + device). The role requires collaboration with both clinical study sites, partners and CROs, ensuring compliance with ISO 14155, ICH-GCP, local regulations, and company SOPs. 
Medical device trial experience is required, while additional exposure to drug and therapeutic trials is an advantage. As we operate globally, good English skills, both spoken and written, are a requirement
Key Responsibilities
• Support study start-up, feasibility, submissions, and essential documentation.
• Conduct and/or support site monitoring (remote and on-site)
• Act as point of contact for investigators and site staff.
• Coordinate and oversee CRO activities and deliverables.
• Maintain the Trial Master File (TMF) and study documentation.
• Track enrollment, product/device accountability, and safety reporting.
• Contribute to study reports and regulatory filings.
Clinical Focus Areas:
• Medical Devices: Core specialty with ISO 14155 expertise.
• Combination Products: Involvement in drug–device interface studies.
• Therapeutics: Familiarity with ICH-GCP drug trials advantageous.
• Collaboration: Working across both sites and CROs.
Qualifications
• Minimum Bachelor’s degree in life sciences, nursing, pharmacy, biomedical engineering, or related field.
• Minimum 2–4 years’ experience as a CRA or CTA, preferably in medical device trials.
• Knowledge of ISO 14155 essential; familiarity with ICH-GCP a plus.
• Experience with both study site and CRO collaboration desirable.
• Strong organizational and communication skills.
• Proficiency with MS Office and clinical trial systems (CTMS, eTMF).
• Willingness to travel (for CRA role).
Interested? Submit your application today! We will review applications on an ongoing basis and hope to fill the position as soon as possible.
The SmartCella group consist of SmartCella Holding AB, ProCella Therapeutics AB, SmartWise AB and SmartCella Solutions AB with a total of 82 employees from more than 20 nationalities. Visa mindre

At Procella Therapeutics, we are developing first-in-class allogeneic regenerative medicines with clinical indications ranging from advanced heart failure to Parkinson’s disease as well as in-house cGMP manufacturing capabilities to advance our portfolio of novel therapies to the clinic. We are now looking for an Analytical Research Technician to join our team.
As an Analytical Research Technician you will work in the process industrialisation group, supporting or performing lab activities to deliver on Procella’s project objectives. The Research Technician supports the team by participating in lab experiments as well as assisting lab coordination by routine management of lab inventories, and equipment. The responsibilities could vary depending on the prevailing project goals of the company and as defined by the line manager.
Key responsibilities
Your contributions and responsibilities will be:
Supporting ongoing experiments through the preparation of reagents or materials or performing certain experiments based on prevailing needs of the team.
Ensuring safety is maintained and delivers CAPAs in response to health and safety, or operational incidents (or near misses).
Support the onboarding of new staff to the department.
Works together with colleagues to plan and coordinate adequate stocking of materials for ongoing lab activities to ensure delivery of project objectives.
Preparation of shipments of product or QC samples to external stakeholders with the support of the lab management team.
Routine lab maintenance and cleaning activities. Superuser to support equipment maintenance and operations.
Assurance of correct equipment and software use.
Tracking delivery of work according to the prevailing work plan and company objectives.
Safety of the team, while on Procella premises.
Ensuring own compliance with company policies and procedures (SOPs).


Practical experience and education You need to have a BSc or equivalent, with minimum 2 years’ relevant work experience. Alternatively, MSc in stem cell biology, immunology or related fields with demonstrable experience in mammalian cell culture and/or flow cytometry. It will be a merit if you also have: - Prior experience with mammalian cell culture. - Experience working with pluripotent stem cells is a plus. - Experience with PCR techniques, flow cytometry, immunocytochemistry, ELISA or similar assays.
Other qualifications/competencies  We believe you need to show/be: - Demonstrable experience with culturing primary cells or cell lines. - Demonstrable experience with flow cytometry. - Fluent in written and spoken English. - Proficient in use of MS Office tools (Word, Powerpoint, Excel, Outlook). - Excellent interpersonal and communication skills, both written and verbal. We will also value: - Knowledge and/or experience with working under GMP or alternative quality system. - Ability to participate in a team and deliver with a positive and constructive approach in daily work. - A trustworthy, honest, and transparent way of working. - Continuous improvement mindset, willingness to learn new skills and grow in a dynamic environment. - A proactive and anticipatory approach in dealing with issues (health and safety, scientific, interpersonal). - Showing and encouraging a mindset for collaboration, to build an inclusive Procella team spirit across departments and teams. - Acting with respect and integrity in interactions with teammates and to all colleagues. - Demonstrating a nurturing a supportive attitude with colleagues. - Being flexible and able to adapt to new challenges or changes as they arise.
Interested? Submit your application today! We will review applications on an ongoing basis and hope to fill the position as soon as possible.
SmartCella is a world-leading biotech company pioneering the future of targeted therapies by combining first-in-class delivery platforms with cutting-edge cell and gene therapies. The SmartCella group consist of SmartCella Holding AB, ProCella Therapeutics AB, SmartWise AB and SmartCella Solutions AB with a total of 82 employees from more than 20 nationalities. Visa mindre

At Procella Therapeutics, we are developing first-in-class allogeneic regenerative medicines with clinical indications ranging from advanced heart failure to Parkinson’s disease as well as in-house cGMP manufacturing capabilities to advance our portfolio of novel therapies to the clinic. We are now looking for an Analytical Research Technician to join our team.
As an Analytical Research Technician you will work in the process industrialisation group, supporting or performing lab activities to deliver on Procella’s project objectives. The Research Technician supports the team by participating in lab experiments as well as assisting lab coordination by routine management of lab inventories, and equipment. The responsibilities could vary depending on the prevailing project goals of the company and as defined by the line manager.
Key responsibilities
Your contributions and responsibilities will be:
Supporting ongoing experiments through the preparation of reagents or materials or performing certain experiments based on prevailing needs of the team.
Ensuring safety is maintained and delivers CAPAs in response to health and safety, or operational incidents (or near misses).
Support the onboarding of new staff to the department.
Works together with colleagues to plan and coordinate adequate stocking of materials for ongoing lab activities to ensure delivery of project objectives.
Preparation of shipments of product or QC samples to external stakeholders with the support of the lab management team.
Routine lab maintenance and cleaning activities. Superuser to support equipment maintenance and operations.
Assurance of correct equipment and software use.
Tracking delivery of work according to the prevailing work plan and company objectives.
Safety of the team, while on Procella premises.
Ensuring own compliance with company policies and procedures (SOPs).


Practical experience and education You need to have a BSc or equivalent, with minimum 2 years’ relevant work experience. Alternatively, MSc in stem cell biology, immunology or related fields with demonstrable experience in mammalian cell culture and/or flow cytometry. It will be a merit if you also have: - Prior experience with mammalian cell culture. - Experience working with pluripotent stem cells is a plus. - Experience with PCR techniques, flow cytometry, immunocytochemistry, ELISA or similar assays.
Other qualifications/competencies  We believe you need to show/be: - Demonstrable experience with culturing primary cells or cell lines. - Demonstrable experience with flow cytometry. - Fluent in written and spoken English. - Proficient in use of MS Office tools (Word, Powerpoint, Excel, Outlook). - Excellent interpersonal and communication skills, both written and verbal. We will also value: - Knowledge and/or experience with working under GMP or alternative quality system. - Ability to participate in a team and deliver with a positive and constructive approach in daily work. - A trustworthy, honest, and transparent way of working. - Continuous improvement mindset, willingness to learn new skills and grow in a dynamic environment. - A proactive and anticipatory approach in dealing with issues (health and safety, scientific, interpersonal). - Showing and encouraging a mindset for collaboration, to build an inclusive Procella team spirit across departments and teams. - Acting with respect and integrity in interactions with teammates and to all colleagues. - Demonstrating a nurturing a supportive attitude with colleagues. - Being flexible and able to adapt to new challenges or changes as they arise.
Interested? Submit your application today! We will review applications on an ongoing basis and hope to fill the position as soon as possible.
SmartCella is a world-leading biotech company pioneering the future of targeted therapies by combining first-in-class delivery platforms with cutting-edge cell and gene therapies. The SmartCella group consist of SmartCella Holding AB, ProCella Therapeutics AB, SmartWise AB and SmartCella Solutions AB with a total of 82 employees from more than 20 nationalities. Visa mindre

SmartCella is a world-leading biotech company pioneering the future of targeted therapies through delivery solutions and advanced therapy development. Founded in 2014, the company is built on globally renowned science and research from Karolinska Institutet in Sweden. SmartCella combines novel delivery platforms, such as the Extroducer (an endovascular delivery device that enables direct injection to hard-to-reach organs and tumors), with cutting-edge development and manufacturing of cell-mediated therapies. The company operates in two business segments: Targeted Deliveries and Regenerative Medicines.
To our Regenerative Medicines segment, the business unit Procella Therapeutics AB, we are now seeking an experienced Senior QC Manager to join the growing QC team. 
About The Position
As Senior QC Manager you will be leading the GMP Quality Control laboratory together with a great team of highly competent colleagues, and you will be working at a patient-focused, growing and developing company that strives to unlock the full potential of cell-based advanced therapies for patients in need.
As a QC Manager, you will be leading a team consisting of three QC members and ensuring all QC activities are scheduled and executed. You will be allocating resources, setting budget, executing analytical technological transfers, ensuring instrument and equipment qualifications, drive development and management of SOPs, methods and their validation/verification while ensuring compliance at the outsourced CLOs. This role will work closely with cross functional teams internally (development, manufacturing, quality and CMC organizations) and reporting to the Head of Quality and Qualified Person. It is a full-time position located at SmartCella's Headquarters in Tullinge, Greater Stockholm Area.
Responsibilities
Leading Procella’s GMP Quality Control laboratory 
Personnel management   
Develop/approve among other SOPs, methods, specification, validation/qualification documentation, reports etc. 
Ensure bioanalytical method validation/verification/qualification is performed according to cGMP
Ensure purchasing of material/reagents/instruments, qualification and maintenance and calibration
Support in validation (IQ/OQ/PQ) activities of equipment and instruments 
QC member in various cross-functionally projects such as tech transfers
Act as an expert and be an advisor regarding quality control issues/queries
Ensure/Lead assay/method tech transfer activities from development laboratories/external CLO to Procella GMP QC laboratory  
Be responsible for GMP compliance within your area and provide oversight of outsourced activities
Responsible for communication with CLOs in analysis issues
Perform method improvement work and trouble-shooting in collaboration with CLOs and development teams
Responsible for developing and setting up new methods for analysis of (release, IPC) for starting material (Master Cell Bank, Working Cell Bank), Drug Product and Raw Materials as needed
Participate/support in authority inspections

Qualifications
You are a strong leader and must have previous experience of management of GMP QC laboratory
You have documented knowledge of in process controls such as automated cell counting, cell viability measurements, media biomarker analysis, or image-based culture analysis tools
You have a scientific background and are familiar with the analysis techniques; among other, flow cytometry, qPCR, ddPCR and ELISA.
Be able to speak / write English fluently
You have an understanding in biological manufacturing and testing (R&D and clinical manufacturing)
A high-level education (university degree or similar) within relevant area such as pharmaceutical, biotech or life science
You have at least 10 years of experience from the quality control within pharmaceutical industry
Extensive GMP knowledge and experience

Personal attributes
You are independent, good at driving your own work forward and you have a good ability to take your own initiatives. You are a natural QC leader who thrives in a role where communication and collaboration are in focus. You can create and maintain rewarding working relationships both externally and internally. Furthermore, with you handle new situations with ease as well as many different issues at the same time.
Equal Opportunity Work
At SmartCella we welcome, and value diversity and we are proud to be an equal opportunity workplace. Please let us know if you require disability-related accommodation or other grounds protected by human rights legislation during the recruitment process so that we can work with you to meet your needs.
If you are interested in this unique opportunity, please submit your application (including cover letter) today. We will handle applications continuously. 
We look forward receiving your application! Visa mindre

SmartCella Solutions is seeking a highly motivated Research Scientist to join our R&D team. The Research Scientist provides scientific expertise, oversees the planning and execution of projects related to cell culture and molecular lab work, and is accountable for delivering these in a timely manner. As a part of our dynamic team, this role would collaborate closely with other scientists to develop, optimize, validate and execute biochemical and/or cellular assays to support R&D projects. This position requires some weekend work.
Areas of responsibilities will include:
Lead the design, development, and execution of immunological assays, including: ELISApot, ELISA, FACs, detection of antigen-specific cells, functional assays, single-cell profiling techniques to characterize immune cell populations, identify exploratory biomarkers, and other relevant techniques.
Develop, optimize, validate and troubleshoot immunological assays and implement new techniques to assess mechanisms of action in a timely manner.
Evaluate, analyze, review raw data, and present results to scientific groups (internally & externally)
Keep abreast of scientific and other relevant literatures.
Work collaboratively in a team environment and independently to deliver against fast timelines.
Maintain a high standard of experimentation and documentations.

Qualifications needed for the role:
Required:
PhD in Molecular Biology, Immunology, Immuno-oncology, or relevant field.
Proven experience in cell culturing, passaging, freeze/thaw, general maintenance of human ES or IPSC or other stem cells.
Hand-on experience in development and implementation of immunological assays, such as: ELISpot, ELISA, FACs, detection of antigen specific cells, cytokine assays, B cell and T cell based assays, serological assays.
Experience in conceptualizing and leading innovative assay development and data analysis.
Demonstrated ability to effectively troubleshoot and solve complex problems.
Experience in working within a fast-paced team environment with a high degree of self-motivation, flexibility, collaboration and organization.
Meticulous laboratory approach, careful adherence to protocols and excellent lab notebook documentation.
Excellent verbal and writing skills for documentation of data, drafting of reports, and communication of progress within team and to manager.

Desired:
Prior experience in DNA/RNA biology is highly desirable.
Experience in cell and gene therapy
Experience with animal disease modelling
Experience with immune repertoire analyses.
Other related skills such as cell transfection/electroporation/nucleofection and basic molecular biology skills would be highly valued.
Strong publication record in an academic background in immunology, immune-oncology or cancer biology
Working knowledge in RNA therapeutic field
Fluent in English (writing and speaking), while fluency in Swedish is appreciated.

Interested? Submit your application today! We will review applications on an ongoing basis.
SmartCella is a world-leading biotech company pioneering the future of targeted therapies by combining first-in-class delivery platforms with cutting-edge cell and gene therapies. The SmartCella group consist of SmartCella Holding AB, ProCella Therapeutics AB, SmartWise AB and SmartCella Solutions AB with a total of 82 employees from more than 20 nationalities. Visa mindre

We are now seeking an IT Support Techicianto our team in Tullinge.
As IT Support Technician you will be the first point of contact when it comes to providing on-site support for SmartCella’s end users at our offices.The role includes troubleshooting and resolving issues with software, hardware and other IT-related problems. You will work closely with the IT Manager to ensure that SmartCella’s IT environment is reliable, secure and up-to-date, and that the users in the organization are receiving in-house support with a high service level.
The role will be on-site five days per week andwill report to the CFO.
Key responsibilities and scope of the role
1st line support of internal users on site for computers, mobile devices, print, network and conference rooms
Responsible for the hardware inventory and PC installations
Management of user accounts and license allocations
Assisting in IT projects and activities
Ensuring IT onboarding and offboarding of users are following the internal procedures


Qualifications & experience
To be successful in this role you need to beself-motivated, curious and service minded as a person. The role requires a “business first” mindset where a functioning IT environment for the end user is always top priority.
Having good communication skills and being fluent in English and Swedish both verbally and in writing is a must. This role is you who havea will to learn and improve within all areas of internal IT Management.
Education/Learning Experience/Work Experience
At least 1 year of experience as a Support Technician or in a similar role
Good knowledge of Windows
A general interest and curiosity in technology
Excellent problem-solving skills
A driver’s license

Experience from the life science or IT industry is beneficial, but not a requirement.
Interested? Submit your application today! We will review applications on an ongoing basis and hope to fill the position as soon as possible.
SmartCella is a world-leading biotech company pioneering the future of targeted therapies by combining first-in-class delivery platforms with cutting-edge cell and gene therapies. The SmartCella group consist of SmartCella Holding AB, ProCella Therapeutics AB, SmartWise AB and SmartCella Solutions AB with a total of 80 employees from more than 25 nationalities. Visa mindre

SmartCella är ett världsledande bioteknikföretag som banar väg för framtidens riktade terapier genom att kombinera förstklassiga leveransplattformar med banbrytande cell- och genterapier. SmartCella gruppen består av SmartCella Holding AB, ProCella Therapeutics AB, SmartWise AB och SmartCella Solutions AB med totalt 70 anställda från mer än 20 nationaliteter.

Vi söker nu en självständigRedoovisningsekonomtill vår redovisningsfunktion för ett föräldravikariat under perioden december 2024 t.o.m augusti 2026.

Som Redoovisningsekonomkommer du att ha följande roll & ansvar:
Leverantörsreskontra, avstämningsarbete och kvalitetssäkring av bokföring
Support vidbokslut (månads-, kvartals-, och årsbokslut) samt vara behjälplig i arbetet med framtagande av kvartalsrapporter och årsredovisning
Hantering av skatte- och momsdeklarationer
Delaktig i att vidareutveckla och effektivisera arbetet inom redovisningen vad gäller upprättande av rutiner och policies samt optimering av processer
Kontakt med samarbetsparter t ex scanning leverantörsfakturor

Det dagliga arbetet kommer ledas av vårHead of Accounting och du kommer ingå i Finance teamet som består av fem personer under ledning av vår CFO.

Kompetens & Kvalifikationer
Vi ser framför oss att du hararbetatett antal år med leverantörsreskontra, har en mångårig erfarenhet av ekonomiarbete och ser fram emot att ta dessa kunskaper vidarei ett nyskapande ochspännande bioteknikföretag.
Du har någon form av eftergymnasial utbildning inom ekonomi/redovisning och erfarenhet från enliknande roll sedan tidigare.
Som person är du självgående, ansvarstagande, relationsskapande och prestigelös. Duhar god känsla för detaljer, är struktureradoch kan prioritera när det behövs.
För att trivas i rollen bör du ha ett intresse av att effektivisera/utveckla processer och rutiner, förmåga att arbeta både självständig och i grupp. Då vi är ett multikulturellt bolag verksamma på en global marknad är det viktigt att du harmycket goda kunskaper i engelska och svenska i både tal och skrift.

Varför SmartCella...Hos oss kommer du att"göra skillnad".Du kommer att vara en del av en resa som kommer att göra skillnad för människors liv.Hos oss kommer du att"vara med och utveckla" vår koncern.Du kommer att delta i attbygga och vidareutveckla vår redovisningsfunktion och driva förbättringsinitiativ i samarbete med kollegor.Hos oss kommer du att "upplevakulturell mångfald".Du kommer vara en del iett mångkulturellt team, som är passionerade och tycker om att ha roligt tillsammans.
Låter det spännande? Skicka in din ansökan idag! Vi kommer att hantera ansökningar löpande och hoppas kunna tillsätta tjänsten i december. Visa mindre

At Procella Therapeutics we provide advanced capabilities within stem cell therapy development and in-house cGMP manufacturing. We have a globally licensed cardiac stem cell therapy in clinical stages and a growing pipeline of stem cell therapies targeting other therapeutic indicators.
As the QCAnalystyou are a technical expert charged with performing and supporting the planning of ongoing lab activities to deliver both theproject and your ownobjectives. Youplan and ensure the delivery of your work in a timely manner, as defined by the QC Manager.
Main responsibilities
Perform all lab functions in compliance with cGMP
Follow written procedures and execute QC testing for the following release tests: Flow Cytometry, ELISA, qPCR, Appearance
Provide lab support, including reagent preparation, instrument and facility cleaning and maintenance, order stock and management of laboratory supplies
Support Supply Chain, QC and QA in receipt and release of starting and raw materials and consumables according to written specifications
Identify and report deviations and test failures
Manage incoming samples for release and stability testing
Develop / revise current/new SOPs and other GMP documentation
Ensure training is current for all job functions performed

You will also be involved in Technology Transfer (into Procella, out to collaborators or internally with the Analytical Development team) depending on the prevailing project goals of the company and as defined by the line manager.
Required qualification and competence
Practical experience:
Demonstrable experience with culturing primary cells or cell lines.
Knowledge and understanding of relevant analytical methods such as flow cytometry, qPCR, or ELISA and follow written procedures with close attention to detail.
Working knowledge of the GxP laboratory environment, and equipment associated with testing of biopharmaceutical products.
Fluent in written and spoken English.
Proficient in use of MS Office tools (Word, Powerpoint, Excel, Outlook).
Excellent interpersonal and communication skills, both written and verbal.

Education:
BSc and/or MSc in a relevant subject area with 2+ years’ relevant work experience.

Other meriting experience/competence:
Prior experience in cell and gene therapy product development in an industry setting.
Prior experience working with pluripotent stem cells.
Prior experience working under a quality system.
Project and people management
Experience with pluripotent stem cell biology and differentiation
Knowledge and understanding of bioreactors, bioprocessing equipment, cell sorting.
Knowledge of ICH Guidelines and Eudralex Volume 4 ATMP Guidelines
Quality by Design methodology, and Design of Experiments
Experience with working under GMP
Membership of a professional scientific body

Interested? Submit your application today! We will review applications on an ongoing basis and hope to fill the position as soon as possible.
_________________________________________________________________________
SmartCella is a world-leading biotech company pioneering the future of targeted therapies by combining first-in-class delivery platforms with cutting-edge cell and gene therapies. The SmartCella group consist of SmartCella Holding AB, ProCella Therapeutics AB, SmartWise AB and SmartCella Solutions AB with a total of 70 employees from more than 24 nationalities. Visa mindre

SmartCella är ett världsledande bioteknikföretag som banar väg för framtidens riktade terapier genom att kombinera förstklassiga leveransplattformar med banbrytande cell- och genterapier. SmartCella gruppen består av SmartCella Holding AB, ProCella Therapeutics AB, SmartWise AB och SmartCella Solutions AB med totalt 70 anställda från mer än 20 nationaliteter.

Vi söker nu en självständigRedovisningsekonomtill vår redovisningsfunktion för ett föräldravikariat under perioden december 2024 t.o.m augusti 2026.

Som Redovisningsekonomkommer du att ha följande roll & ansvar:
Leverantörsreskontra, avstämningsarbete och kvalitetssäkring av bokföring
Support vidbokslut (månads-, kvartals-, och årsbokslut) samt vara behjälplig i arbetet med framtagande av kvartalsrapporter och årsredovisning
Hantering av skatte- och momsdeklarationer
Delaktig i att vidareutveckla och effektivisera arbetet inom redovisningen vad gäller upprättande av rutiner och policies samt optimering av processer
Kontakt med samarbetsparter t ex scanning leverantörsfakturor

Det dagliga arbetet kommer ledas av vårHead of Accounting och du kommer ingå i Finance teamet som består av fem personer under ledning av vår CFO.

Kompetens & Kvalifikationer
Vi ser framför oss att du hararbetatett antal år med leverantörsreskontra, har en mångårig erfarenhet av ekonomiarbete och ser fram emot att ta dessa kunskaper vidarei ett nyskapande ochspännande bioteknikföretag.
Du har någon form av eftergymnasial utbildning inom ekonomi/redovisning och erfarenhet från enliknande roll sedan tidigare.
Som person är du självgående, ansvarstagande, relationsskapande och prestigelös. Duhar god känsla för detaljer, är struktureradoch kan prioritera när det behövs.
För att trivas i rollen bör du ha ett intresse av att effektivisera/utveckla processer och rutiner, förmåga att arbeta både självständig och i grupp. Då vi är ett multikulturellt bolag verksamma på en global marknad är det viktigt att du harmycket goda kunskaper i engelska och svenska i både tal och skrift.

Varför SmartCella...Hos oss kommer du att"göra skillnad".Du kommer att vara en del av en resa som kommer att göra skillnad för människors liv.Hos oss kommer du att"vara med och utveckla" vår koncern.Du kommer att delta i attbygga och vidareutveckla vår redovisningsfunktion och driva förbättringsinitiativ i samarbete med kollegor.Hos oss kommer du att "upplevakulturell mångfald".Du kommer vara en del iett mångkulturellt team, som är passionerade och tycker om att ha roligt tillsammans.
Låter det spännande? Skicka in din ansökan idag! Vi kommer att hantera ansökningar löpande och hoppas kunna tillsätta tjänsten i december. Visa mindre

At SmartWise we are developing and manufacturing a first-in-class endovascular delivery device whichenables direct tissue/organ infusions to hard-to-reach organs and tumors. Due to the unique mechanical properties and design, in animal studies, multiple infusions could be performed in extravascular tissue after exit of the vascular system, opening the door for future research into precise cell and biologic therapy delivery and repurpose small molecules for greater and safe local effects.
We are now looking for a Regulatory and Quality Engineer to join our team.
This is a fantastic opportunity for you who have been working a couple of years in the medical device field and want to develop a careertogether with a small team of experienced colleagues.
Key responsibilities
Performance of routine quality and regulatory tasks
Support of regulatory filings and submissions
Maintenance of the QMS, incl SOP updates andhandling CAPAs and deviations etc
Support of supplier qualifications
Routine monitoring of regulatory landscape
Support of internal and external audits

Practical experience
Understanding of medical device regulatory landscape (North America/EU) incl current MDR implementation, ISO13485, 21CFR
Technical documentation experience
Understanding of internal and external audits
Root cause investigations and CAPA concepts
Microsoft OS proficiency
Fluency in English is mandatory, Swedish highly preferred

Education
STEM subject or similar, Bachelor-level or equivalent.

Personal qualifications
Enjoy working in a small team anda regulated environment
Detail- and result oriented with the ability to work self-directed with supervision
A fast learner with solutions-oriented approach
An entrepreneurial mindset with a can-do attitude and the ability to adapt to change

Previous hands-on experience in regulatory filings of medical devices; experience in go-to-market as well as post-market surveillance of medical devices; additional territory experience, e.g. Korea, Japan are a merit
Interested? Submit your application today! We will review applications on an ongoing basis and hope to fill the position as soon as possible.
SmartCella is a world-leading biotech company pioneering the future of targeted therapies by combining first-in-class delivery platforms with cutting-edge cell and gene therapies. The SmartCella group consist of SmartCella Holding AB, ProCella Therapeutics AB, SmartWise AB and SmartCella Solutions AB with a total of 69 employees from more than 20 nationalities. Visa mindre

At Procella Therapeutics we provide advanced capabilities within stem cell therapy development and have inhouse cGMP manufacturing. We have globally licensed cardiac stem cell therapy in clinical stages (collaboration with AstraZeneca) and a growing pipeline of stem cell therapies.
We are now seeking a highly motivated individualto join us as QA Specialist – Microbiological Quality Assurance.
About The Position
This isa role for someone who is ready to work in a QA role with many internal and external contacts. At Procella you will be part of a great team with high competence, and you will be working at a patient-focused, growing and developing company that makes a difference. As a QA Specialist – Microbiological Quality Assurance, you will provide QA oversight towards GMP clean rooms (grade D - Grade A), while ensuring cGMP of internal manufactured products. This role will work closely with cross functional teams internally (development, manufacturing, QC). Reporting to the Head of Quality and Qualified Person, this full-time position is located at Procella Headquarters in Tullinge, Greater Stockholm Area.
Responsibilities
Provide Quality oversight for environmental monitoring of manufacturing facility and cleaning verifications
QA representative in validation activities (CV) of facilities, equipment/instruments, material transfer and certification activities (gowning)
Ensure facility and quality systems state of compliance with internal requirements and appropriate regulations
Lead/Participate in developing action plans to correct deficiencies to ensure the adequate microbiological quality of the site facilities, utilities, processes, and products
Analyze and interpret environmental monitoring data, identify trends, and implement adequate corrective actions
QA lead in design and development of Aseptic Process Simulations / Media Fills
Handle various documentation revisions (including SOPs etc.)
QA member in various cross-functionally teams and projects (tech transfers) to ensure microbial contamination prevention and control requirements are met for new product introductions, facility adaptations, and process changes
Act as an expert and be an advisor regarding GMP in quality issues from a environmental view
Develop and deliver training programs to facility staff on contamination prevention and control, Cleanroom behavior, microbial theory and hygiene best practices
Be responsible for GMP compliance within your area
Responsible QA for potential deviations, risk assessments and change controls within own area
Lead and guide Investigations of monitoring excursions, contamination incidents, and deviations from contamination control procedures.
Handle GMP quality related issues both internally and externally with Procella’s GMP suppliers
Support/Participate in audits and regulatory inspections PharmaceuticalMicrobiology subject matter expert
Quality oversight of CLOs

Qualifications
A high-level education (university degree or similar) within relevant area(preferably in microbiology)
GMP experience in the biologics industry, with direct QA or directly relevant QC Microbiology experience
Strong knowledge of contamination control principles, practices, and regulations (e.g., FDA, EMA)
Working knowledge of microbiological testing methods, media challenges, environmental monitoring, clean room qualification and management, and microbiological control strategy required
You must have experience of working with GMP environmental monitoring / microbial laboratory
Be able to speak / write Swedish and English fluently

Personal attributes
You are independent, good at driving your own work forward and you have a good ability to take your own initiatives. You are a natural QA leader who thrives in a role where communication and collaboration are in focus. You can create and maintain rewarding working relationships both externally and internally. Furthermore, with you handle new situations with ease as well as many different issues at the same time.
Equal Opportunity Work
At Procella we welcome and support differences and diversity and we are proud to be an equal opportunity workplace. Please let us know if you require disability-related accommodation or other grounds protected by human rights legislation during the recruitment process so that we can work with you to meet your needs.
If you are interested in this unique opportunity, please submit your application (including a cover letter) today. We will review applications on an ongoing basis and hope to fill the position as soon as possible.

_________________________________________________________________________
SmartCella is a world-leading biotech company pioneering the future of targeted therapies by combining first-in-class delivery platforms with cutting-edge cell and gene therapies. The SmartCella group consist of SmartCella Holding AB, ProCella Therapeutics AB, SmartWise AB and SmartCella Solutions AB with a total of 69 employees from more than 20 nationalities. Visa mindre

At Procella Therapeutics we provide advanced capabilities within stem cell therapy development and have inhouse cGMP manufacturing. We have a globally licensed cardiac stem cell therapy in clinical stages (collaboration with AstraZeneca) and a growing pipeline of stem cell therapies.
We are seeking a highly motivated Senior Project Manager. The Senior Project Manager, reporting to the Head of Procella, will lead and manage complex projects in the field of targeted delivery of cell therapies a new modalities, tissue-engineered products, and other advanced medicinal products. This role requires a deep understanding of the regulatory landscape, manufacturing processes, and clinical development pathways specific to ATMPs.
The successful candidate will oversee cross-functional teams to ensure timely and on-budget delivery of projects while maintaining the highest standards of quality and compliance. The rolewill also need to coordinate work within a cross-functional team of other heads of department, scientists and research technicians, collaborate across functional groups internally and externally. This position is ideal for an individual who is driven and passionate about cell therapy in a fast-paced one-team collaborative environment.
Key Responsibilities
Project Leadership:
Lead the planning, execution, and closing of ATMP projects, ensuring alignment with company goals and regulatory requirements.
Stakeholder Management:
Develop and manage detailed project plans, timelines, and budgets.
Coordinate and oversee the work of cross-functional project teams, including R&D, regulatory, clinical, and manufacturing departments.
Act as the primary point of contact for project stakeholders, including internal teams, external partners, and regulatory bodies.
Facilitate effective communication and collaboration among stakeholders to ensure project objectives are met.
Prepare and deliver regular project updates, presentations, and reports to senior management and other stakeholders.
Regulatory Compliance:
Ensure all project activities comply with relevant regulatory requirements and guidelines for ATMPs (e.g., FDA, EMA, GMP).
Coordinate regulatory submissions and interactions with regulatory authorities.
Stay updated on changes in the regulatory landscape and assess their impact on ongoing and future projects.
Risk Management:
Identify potential project risks and develop mitigation strategies.
Monitor project progress and adjust plans as necessary to address emerging risks and issues.
Conduct regular risk assessments and update risk management plans accordingly.
Quality Assurance:
Ensure all project deliverables meet the highest standards of quality and compliance.
Collaborate with Quality Assurance teams to conduct audits and reviews of project activities and outputs.
Implement continuous improvement initiatives to enhance project performance and outcomes.
Budget and Resource Management:
Develop and manage project budgets, ensuring efficient use of resources.
Monitor project expenditures and take corrective actions to address budget variances.
Coordinate resource allocation and utilization across project teams.
Team Leadership and Development:
Mentor and guide project team members, fostering a culture of collaboration and excellence.
Conduct performance reviews and provide feedback to team members.
Identify training and development needs and facilitate professional growth opportunities for team members
PREFERRED QUALIFICATIONS
Ph.D. in cell and/or molecular biology, biochemistry, biotechnology or another relevant field with at least 10+ years of of relevant experience in Project Management in ATMP
MBA desirable

Proven experience in Senior Project Manager - Advanced Therapy Medicinal Products (ATMP)
Interested? Submit your application today! We will review applications on an ongoing basis and hope to fill the position as soon as possible.
SmartCella is a world-leading biotech & medtech company pioneering the future of targeted therapies by combining first-in-class delivery platforms with cutting-edge cell and gene therapies. The SmartCella group consist of SmartCella Holding AB, ProCella Therapeutics AB, SmartWise AB and SmartCella Solutions AB with a total of 69 employees from more than 20 nationalities. Visa mindre

We are now seeking an IT Manager to our team in Tullinge.

As IT Manager you will have the operational responsibility for the application portfolio, information security and the use of technology at SmartCella. The work will span across process setup, routine management, incident handling, infrastructure oversight and vendor management. You will work closely with our service desk provider (Advania), vendors and internal stakeholders to ensure high performance, security, reliability and cost effectiveness. You will report to the CFO.

Key responsibilities and scope of the role

- Ownership of SmartCella's IT architecture, solutions and technical environments

- SmartCella's IT and information security strategy and roadmap, including related policies such as IT-policy, Information Security Policy, Business Continuity Policy and Disaster Recovery Policy, standard operating procedures (SOPs) and guidelines to meet and maintain business and legal standards and medical technology regulatory requirements.

- Together with our “Help desk” service provider Advania, manage day-to-day activities such as support to end-users and incident management, provide technical support and maintenance of local applications.

- IT and information security-related risks and their management

- Responsible for supplier management at a strategic, tactical and operational level for example with the partner for IT operations, maintenance and support. This includes tracking costs and deliveries in accordance with existing contracts.

- Contact person for external actors regarding IT and information security issues

- Sounding board for SmartCella's management team and the business in IT-related matters such as new solutions, applications and platforms

- Responsibility for driving IT-related business development projects and change

- Overall responsibility for rental agreements, service contracts etc for office facilities.

Qualifications & experience

Skills/Knowledge/Languages

You have a pro-active approach, are self-motivated and structured as a person with a non-prestigious, responsive, and analytical interest in identifying areas for improvement. You enjoy having overall responsibility for the IT function and is equally happy to step in where needed. You have the ability to transform technical ? functional requirements in an understandable way, is a skilled communicator, fluent in English and Swedish both verbally and in writing.

Education/Learning Experience/Work Experience

To be successful in this role you need to have:

- An academic degree and at least five years of experience in a similar position at both strategic and operational level in an international business.

- Broad knowledge of IT, life cycle management of software, sourcing and implementation

- Updated knowledge of market trends and technology development

- Experience in managing service agreements and procurement of software and services

- Experience of project management and different methods

- Demonstrated experience working in an IT Operations position including vendor management, or similar position.

- Solid knowledge of infrastructure components and practical know-how in application and user support

Experience from the biotech/life science industry and from a listed environment is a merit. If you also have worked with IT in regulated businesses, it will be beneficial.

Interested? Submit your application today! We will review applications on an ongoing basis and hope to fill the position as soon as possible.

SmartCella is a world-leading biotech & medtech company pioneering the future of targeted therapies by combining first-in-class delivery platforms with cutting-edge cell and gene therapies. The SmartCella group consist of SmartCella Holding AB, ProCella Therapeutics AB, SmartWise AB and SmartCella Solutions AB with a total of 65 employees from more than 20 nationalities. Visa mindre

At Procella Therapeutics we provide advanced capabilities within stem cell therapy development and have inhouse cGMP manufacturing. We have a globally licensed cardiac stem cell therapy in clinical stages (collaboration with AstraZeneca) and a growing pipeline of stem cell therapies.
We are now seeking moreScientists/ Sr. Scientiststo join our Process Development team.
Position overview
As a Senior Scientist /Scientist you will work in the process development group, proposing the scientific direction of ongoing work and supporting/executing associated wet lab activities to deliver on project objectives. In this role, you will be working closely with other colleagues in an agile, multidisciplinary environment, to deliver innovative cell therapies and/or novel technology solutions to accelerate the translation of cell therapies to clinic. The Senior Scientist / Scientist may be tasked with performing process development, QC testing, product manufacturing, or analytical method development depending on the prevailing project goals of the company.

Key responsibilities
Your contributions and responsibilities will be:
Drive the scientific direction of various projects by proposing development strategies, designing experiments, coordinating teams and planning of ongoing labwork.
Delivery of project objectives on time, on budget, and to a suitable level of quality to meet project milestones, including participating in daily labwork.
Preparation of data reports and present data to internal or external stakeholders.
Routine laboratory and equipment maintenance operations, including cleaning of lab areas and equipment, correct use and maintenance of lab equipment, ensuring availability of raw materials and consumables and support for overall inventory and budget management.
Drafting of SOPs and performing training of staff.


Required qualifications and competence
To be successful in the position you need:
PhD in a relevant subject area, or BSc and/or MSc in a relevant subject area with 3+ years’ relevant work experience for the Scientist position.
PhD in a relevant subject area, and 4+ years’ relevant work experience, or BSc and/or MSC in a relevant area and 6+ year’s relevant work experience for the Senior Scientist position.
Demonstrable experience with bioprocess development either in Biopharma, CDMO or a similar organization, including demonstrable expertise in Design of Experiments, bioreactors, upstream/downstream bioprocessing of cells.

And/or
A strong background in developmental biology, working withpluripotent stem cells, use, development, and optimization ofdifferentiation methods to cardiac, neuronal or other therapeutically relevant cell types.
Knowledge and prior practical experience with relevant analytical methods such as flow cytometry, qPCR, or ddPCR.
Proficient in use of MS Office tools.
Fluent in written and spoken English and have excellent interpersonal and communication skills, both written and verbal.

It will be a merit if you have prior experience/knowledge/can demonstrate:
Cell and gene therapy product development in an industry setting.
Previous experience working with bioprocessing equipment (for example:bulk electroporation, cell sorting (magnetic or fluorescence based), buffer exchange, vialling, controlled rate freezing).
Innovative and entrepreneurial mindset.
Working under a quality system.
Project and people management.
Familiarity with Lean, Six Sigma, or similar methodologies.
Quality by Design methodology.
Working under GMP.


Interested? Submit your application today! We will review applications on an ongoing basis and hope to fill the position as soon as possible.
SmartCella is a world-leading biotech & medtech company pioneering the future of targeted therapies by combining first-in-class delivery platforms with cutting-edge cell and gene therapies. The SmartCella group consist of SmartCella Holding AB, ProCella Therapeutics AB, SmartWise AB and SmartCella Solutions AB with a total of 60 employees from more than 20 nationalities. Visa mindre

SmartCella Solutions is seeking a highly motivated Scientist/Senior Scientist to join our R&D team on our immunology project. The Scientist provides scientific expertise, oversees the planning and execution of projects and is accountable for delivering these in a timely manner. As a part of our dynamic team, this role would collaborate closely with other scientists to develop, optimize, validate and execute biochemical and/or cellular assays to support R&D projects, some weekend work will be required. The role will be located at SmartCella Solutions AB/ Working LAB, Nanna Svartzväg 2 in Solna.

Key responsibilities

- Lead the design, development, and execution of immunological assays, including: ELISApot, ELISA, FACs, detection of antigen-specific cells, functional assays, single-cell profiling techniques to characterize immune cell populations, identify exploratory biomarkers, and other relevant techniques.

- Develop, optimize, validate and troubleshoot immunological assays and implement new techniques to assess mechanisms of action in a timely manner.

- Evaluate, analyze, review raw data, and present results to scientific groups (internally & externally)

- Keep abreast of scientific and other relevant literatures.

- Work collaboratively in a team environment and independently to deliver against fast timelines.

- Maintain a high standard of experimentation and documentations.

Qualifications needed for the role

- Excellent verbal and writing skills for documentation of data, drafting of reports, and communication of progress within team and to manager.

- PhD in Molecular Biology from Immunology, Immuno-oncology or Cancer Biology field.

- An additional 2+ years relevant industry or academia work experience in immunology.

- Proven hands-on experience in the development and implementation of immunological assays, including ELISpot, ELISA, FACs, detection of antigen specific cells, cytokine assays, B cell and T cell based assays, serological assays.

- Experience with immune repertoire analyses.

- Experience in conceptualizing and leading innovative assay development and data analysis.

- Demonstrated ability to effectively troubleshoot and solve complex problems.

- Experience in working within a fast-paced team environment with a high degree of self-motivation, flexibility, and organization.

- Meticulous laboratory approach, careful adherence to protocols and excellent lab notebook documentation.

It will be beneficial to also have:

- Prior experience in RNA biology is highly desirable.

- Experience in cell and gene therapy

- Strong publication record in an academic background in immunology, immune-oncology or cancer biology

- Working knowledge in RNA therapeutic field

- Previous experience in in vivo disease modeling within immunology is highly desirable.

Interested? Submit your application today! We will review applications on an ongoing basis and hope to fill the position as soon as possible.



SmartCella is a world-leading biotech & medtech company pioneering the future of targeted therapies by combining first-in-class delivery platforms with cutting-edge cell and gene therapies. The SmartCella group consist of SmartCella Holding AB, ProCella Therapeutics AB, SmartWise AB and SmartCella Solutions AB with a total of 65 employees from more than 20 nationalities. Visa mindre

SmartCella är ett världsledande bioteknik- och medicinföretag som banar väg för framtidens riktade terapier genom att kombinera förstklassiga leveransplattformar med banbrytande cell- och genterapier. SmartCella gruppen består av SmartCella Holding AB, ProCella Therapeutics AB, SmartWise AB och SmartCella Solutions AB med totalt 60 anställda från mer än 20 nationaliteter.

Vi söker nu en Head of Accounting/ Redovisningschef som kan bygga upp vår framtida redovisningsfunktion.



Roll & Ansvar

- Ansvara för koncernredovisning och konsolidering av månads-, kvartals- och årsbokslut

- Ansvara för koncernbolagens redovisning och rapportering

- Analys av koncernens resultaträkning, balansräkning- och kassaflöde samt relevanta finansiella nyckeltal

- Upprättande av kvartalsrapporter och årsredovisning

- Säkerställa efterlevnaden av IFRS, lokal GAAP

- Kontakt med revisorer och rådgivare

- Driva och utveckla rutiner och processer kopplade till koncernredovisning och rapportering

- Underhålla och utveckla ekonomihandbok

- Kontinuerligt arbeta med utveckling och förändringsprojekt

Fokus 2024 kommer ligga på att bygga upp en intern redovisningsfunktion för SmartCella koncernen, implementera nytt redovisnings- och konsolideringssytem samt övertagande av redovisning från extern part. Till din hjälp kommer du ha en Accountant/ Redovisningsekonom (ny roll).



Kompetens & Kvalifikationer

För att lyckas i rollen behöver du ha 8-10 års erfarenhet från en liknande roll i ett noterat bolag eller från revison och därefter från bolag. Vidare ser vi att du har mycket god erfarenhet av koncernredovisning, konsolidering och IFRS samt erfarenhet av något konsolideringsverktyg. Har du tidigare erfarenhet av insourcing av en ekonomifunktion är det meriterande. Din utbildningsbakgrund är inom ekonomi på högskolenivå.

Som person är du van att arbeta proaktivt, har god känsla för detaljer och kan samtidigt lyfta blicken för att se helheten. Du är noggrann, strukturerad och levererar arbete med god kvalitet. Då du kommer att arbeta med samtliga koncernens bolag är teamkänsla, kommunikativ förmåga och lyhördhet viktigt för framgång, liksom mycket goda kunskaper i engelska och svenska.

Varför SmartCella....

Hos oss kommer du att "göra skillnad".
Du kommer att vara en del av en resa som kommer att göra skillnad för människors liv.

Hos oss kommer du att "vara med och utveckla" vår koncern.
Du kommer att bygga, utveckla och hantera vår redovisningsfunktion och driva förbättringsinitiativ i samarbete med kollegor och samarbetspartners.

Hos oss kommer du att "uppleva kulturell mångfald".
Du kommer vara en del i ett mångkulturellt team, som är passionerade och tycker om att ha roligt tillsammans.

Låter det spännande? Skicka in din ansökan idag! Vi kommer att hantera ansökningar löpande och hoppas kunna tillsätta tjänsten så snart som möjligt. Visa mindre

At Procella Therapeutics we provide advanced capabilities within stem cell therapy development and have inhouse cGMP manufacturing. We have a globally licensed cardiac stem cell therapy in clinical stages (collaboration with AstraZeneca) and a growing pipeline of stem cell therapies.

We are now seeking a motivated Scientist/Senior Scientist to join our Process Development team.

Position overview

As a Senior Scientist / Scientist you will work in the process development group, proposing the scientific direction of ongoing work and supporting/executing associated wet lab activities to deliver on project objectives. In this role, you will be working closely with other colleagues in an agile, multidisciplinary environment, to deliver innovative cell therapies and/or novel technology solutions to accelerate the translation of cell therapies to clinic. The Senior Scientist / Scientist may be tasked with performing process development, QC testing, product manufacturing, or analytical method development depending on the prevailing project goals of the company.



Key responsibilities

Your contributions and responsibilities will be:

- Drive the scientific direction of various projects by proposing development strategies, designing experiments, coordinating teams and planning of ongoing labwork.

- Delivery of project objectives on time, on budget, and to a suitable level of quality to meet project milestones, including participating in daily labwork.

- Preparation of data reports and present data to internal or external stakeholders.

- Routine laboratory and equipment maintenance operations, including cleaning of lab areas and equipment, correct use and maintenance of lab equipment, ensuring availability of raw materials and consumables and support for overall inventory and budget management.

- Drafting of SOPs and performing training of staff.

Required qualifications and competence

To be successful in the position you need:

- PhD in a relevant subject area, or BSc and/or MSc in a relevant subject area with 2+ years’ relevant work experience for the Scientist position.

- PhD in a relevant subject area, and 4+ years’ relevant work experience, or BSc and/or MSC in a relevant area and 6+ year’s relevant work experience for the Senior Scientist position.

- Demonstrable experience with bioprocess development either in Biopharma, CDMO or a similar organization, including demonstrable expertise in Design of Experiments, bioreactors, upstream/downstream bioprocessing of cells.

- Knowledge and prior practical experience with relevant analytical methods such as flow cytometry, qPCR, or ddPCR.

- Proficient in use of MS Office tools.

- Fluent in written and spoken English and have excellent interpersonal and communication skills, both written and verbal.

It will be a merit if you have prior experience/knowledge/can demonstrate:

- Cell and gene therapy product development in an industry setting.

- Innovative and entrepreneurial mindset.

- Working under a quality system.

- Project and people management.

- Familiarity with Lean, Six Sigma, or similar methodologies.

- Quality by Design methodology.

- Working under GMP.

Interested? Submit your application today! We will review applications on an ongoing basis and hope to fill the position as soon as possible.

SmartCella is a world-leading biotech & medtech company pioneering the future of targeted therapies by combining first-in-class delivery platforms with cutting-edge cell and gene therapies. The SmartCella group consist of SmartCella Holding AB, ProCella Therapeutics AB, SmartWise AB and SmartCella Solutions AB with a total of 60 employees from more than 20 nationalities. Visa mindre

At Procella Therapeutics we provide advanced capabilities within stem cell therapy development and have inhouse cGMP manufacturing. We have globally licensed cardiac stem cell therapy in clinical stages (collaboration with AstraZeneca) and a growing pipeline of stem cell therapies.

We are now seeking a Warehouse Technician to join our Supply Chain team.

This is an entry level position where you need some (6 months) experience of working in a warehouse environment with documentation surrounding incoming and outgoing materials. The role requires fluency in English, both written and spoken.

We believe you have some form of post-secondary education. Previous work in a warehouse is required and experience from the pharma/life science industry would be meriting.

It is a full-time job located at Procella Headquarters in Tullinge.



Key tasks & responsibilities:

- Physically retrieving material from the warehouse and bringing it to the labs.
- Follow approved SOPs for inspection, cleaning, documenting and labeling materials for laboratory use.
- Use our digital inventory tracking tool daily and support the administration of this software.
- Follow SOPs for appropriate dress and behavior in the development labs.
- Bring in materials and supplies to the development labs and proactively work to maintain stock levels
- Under the guidance Supply Chain Manager, organize and maintain inventory stock in specified areas of the building.
- Assist in coordinating service and technical visits from suppliers under the direction of the Supply Chain Manager.

- Autoclave water and other materials as required after training, and according to SOPs.

Interested? Submit your application today! We will review applications on an ongoing basis and hope to fill the position as soon as possible.

________________________________________________________________________

SmartCella is a world-leading biotech & medtech company pioneering the future of targeted therapies by combining first-in-class delivery platforms with cutting-edge cell and gene therapies. The SmartCella group consist of SmartCella Holding AB, ProCella Therapeutics AB, SmartWise AB and SmartCella Solutions AB with a total of 60 employees from more than 20 nationalities. Visa mindre

Procella Therapeutics AB is a start-up biopharmaceutical company on a mission to create stem cell-based therapy for heart disease and we are seeking a highly motivated individual to join our team.

As Supply Chain Manager you are responsible for overseeing all activities regarding incoming Starting & Raw Materials, consumables, and reagents both for R&D and GMP organizations. The department will assure compliance to Procella quality systems, registered files and current regulatory requirements and quality criteria’s regarding management of incoming materials. Further scope of the role include procurement, issuing supply agreements and material service agreements. You will report directly to the Head of CMC.

This full-time position is located at Procella Headquarters in Tullinge, Greater Stockholm Area.

Qualifications and requirements

The ideal candidate would have at least 5 years proven supply chain management / procurement experience preferably in a clean room or under GMP manufacturing.

Project management skills would also be beneficial in this role.

Your formal background should be BSc or above in life science or equivalent.

Languages (written and spoken): Swedish and English

Key tasks and responsibilities

- Actively monitoring and managing the inventory in order to maintain a stock of raw materials at an appropriate level.

- Responsible for budget within own organization (training and manufacture supply ordering within scope)

- Document and monitor quality issues, initiate, review and approve change cases within own organization.

- Document, investigate and approve deviations along with QA oversight.

- Author, review and approve documentation within own organization, such as SOPs, supply / Service agreements, supplier/manufacturer qualifications.

- Ensure materials used for GMP activities comply with cGMP and Procella QMS (starting materials, raw materials, packaging materials), with stakeholder input in RM identification, qualification, and RM specifications.

- Ensure supply / service agreements are negotiated and developed for starting and raw materials, as well as for external service providers.

- Problem solving of supply chain issues, along with support from QA and line manager

- Participate and collaborate in inspections from authorities or audits from other companies, in the capacity of supply chain manager.

Why Procella is a great next step for you!

- You’ll make a difference.

We are on a mission to develop treatment for patients running out of options and you will be part of a journey that will make a difference to people’s lives.

- You’ll make your mark as part of our future

You will build, improve and manage our supply chain management function to ensure a reliable and sustainable eco system. You will drive supply chain initiatives in collaboration with colleagues and business owners.

- You’ll feel welcome from day one

We’re a multicultural team, who are collaborative, passionate and enjoys having fun together. Everyone in the "SmartCella family" cares as much as you do about making a positive difference.

Interested? Submit your application today! We will review applications on a ongoing basis and hope to fill the position as soon as possible.

The Smartcella group of companies is focused on developing early-stage biotechnology and medical devices to bring them to the market. The group consists of Procella Therapeutics AB, Smartwise AB, SmartCella Solutions AB and the mother company SmartCella Holding AB.

Procella is a regenerative medicine biotech company focusing on the manufacturing of a cardiac progenitor cell therapy product to treat heart failure. Smartwise is a medical device company developing a novel infusion catheter for precise delivery of drugs and advanced therapeutics and SmartCella Solutions is focused on developing early-stage projects in close collaboration with academia in the field of cell therapy and re-generative medicine. The group strives to bring new therapies and devices to patients in the most safe, efficient, and timely way possible. Visa mindre

At Procella Therapeutics we provide advanced capabilities within stem cell therapy development and have inhouse cGMP manufacturing. We have globally licensed cardiac stem cell therapy in clinical stages (collaboration with AstraZeneca) and a growing pipeline of stem cell therapies.

We are now seeking a highly motivated individual as Senior QA Manager to join our growing QA team.

About The Position

This is a role for someone who is ready to work in a senior QA role with many internal and external contacts. At Procella you will be part of a great team with high competence, and you will be working at a patient-focused, growing and developing company that makes a difference. As a QA Manager, you will provide QA oversight of outsourced activities (CLO’s, starting material suppliers and manufacturers), while ensuring cGMP of internal manufactured products. This role will work closely with cross functional teams internally (development, manufacturing, QC, CMC). Reporting to the Head of Quality, this full-time position is located at Procella Headquarters in Tullinge, Greater Stockholm Area.

Responsibilities

- Handle various documentation revisions (including SOPs etc.)

- QA representative in validation activities (IQ/OQ/PQ) of facilities, equipment/instruments, computerized systems etc.

- Support in development of quality agreements with suppliers, partners, and CLOs

- QA member in various cross-functionally projects such as tech transfers

- Act as an expert and be an advisor regarding GMP in quality issues

- Develop and perform GMP training within Procella

- Be responsible for GMP compliance within your area
- Ensure products, processes, systems and procedures are in compliance with relevant authority requirements (FDA, EMA, ICH etc) and Procella procedures
- Handle GMP quality related issues both internally and externally with Procella’s GMP suppliers

- Support in quality evaluation of suppliers and participate in the continuous follow-up
- Handle, review and approve quality related documentation
- Conduct/participate/support in audits and inspections

Qualifications

- You must have experience of working with Quality Management System (writing, reviewing and approving SOPs and other quality related documentation)
- be able to speak / write Swedish and English fluently
- you have an understanding in biological manufacturing and testing (R&D and clinical manufacturing)
- A high-level education (university degree or similar) within relevant area such as pharmaceutical, biotech or life science
- You have at least 7 years of experience from the pharmaceutical industry, preferably within QA
- Extensive GMP knowledge and experience

Personal attributes

You are independent, good at driving your own work forward and you have a good ability to take own initiatives. You are a natural QA leader who thrives in a role where communication and collaboration are in focus. You can create and maintain rewarding working relationships both externally and internally. Furthermore, with you handle new situations with ease as well as many different issues at the same time.

Equal Opportunity Work

At Procella we welcome and support diversity and we are proud to be an equal opportunity workplace. Please let us know if you require disability-related accommodation or other grounds protected by human rights legislation during the recruitment process so that we can work with you to meet your needs.

If you are interested in this unique opportunity, please submit your application (including a cover letter) today. We will review applications on an ongoing basis and hope to fill the position as soon as possible.

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SmartCella is a world-leading biotech & medtech company pioneering the future of targeted therapies by combining first-in-class delivery platforms with cutting-edge cell and gene therapies. The SmartCella group consist of SmartCella Holding AB, ProCella Therapeutics AB, SmartWise AB and SmartCella Solutions AB with a total of 60 employees from more than 20 nationalities. Visa mindre

Procella Therapeutics AB is a start-up biopharmaceutical company on a mission to create stem cell-based therapy for heart disease and is seeking a motivated Manufacturing Engineer to join the growing manufacturing team. If you are interested in this unique opportunity, please submit your application (including a cover letter).

About The Position

We are seeking a highly motivated individual to join us as a Manufacturing Engineer. The Manufacturing Engineer will be part of the manufacturing team and will be responsible for producing stem-cell for clinical and commercial use. At Procella you will be part of a great team with high competence, and you will be working at a patient-focused, growing, and developing company that makes a difference. This role will work closely with cross-functional teams internally (development, manufacturing, QC, CMC, and regulatory). Reporting to the Head of Production, this full-time position is located at Procella Headquarters in Tullinge, Greater Stockholm Area.

Responsibilities

Support the daily activities in the laboratory and GMP facility

Support cross-functional activities related to manufacturing, process development

Manufacturing of drug substances and drug products for clinical and future commercial use in accordance with regulatory requirements

Execute GMP processes according to production schedules and instructions (e.g., MBR, SOP, and work instructions)

Comply with company policies and standards, risk assessments, instructions, and protocols to produce stem cells batches

Prepare, review, and revise GMP documentation

Participate in tech transfer activities

Coordinate periodic calibration, and maintenance and act as a superuser for equipment and instruments

Handling CAPA and initiation of deviation

Supervise and train team members in cleanroom environments

Skills

Ability to work using a good aseptic technique.

Good understanding and application of GMP and regulatory requirements.

Experience in working in GMP for clinical or commercial use

Good understanding of biological pharmaceutical manufacturing

Qualifications

B.S in Life science or relevant areas is preferred

experience of working in a regulated environment, ideally with upstream and/or downstream processes

Be able to speak/write Swedish and English fluently

You understand biological manufacturing and testing (R&D and clinical manufacturing)

You have at least 3 years of experience in the pharmaceutical industry, preferably in biopharmaceuticals

Extensive GMP knowledge and experience

Personal attributes

You are independent, good at driving your work forward and you have a good ability to take initiative. You are a natural leader who thrives in a role where communication and collaboration are in focus. You can create and maintain rewarding working relationships both externally and internally. Furthermore, with you handle new situations with ease as well as many different issues at the same time.

Equal Opportunity Work

At Procella we welcome, and support differences and diversity and we are proud to be an equal opportunity workplace. Please let us know if you require disability-related accommodation or other grounds protected by human rights legislation during the recruitment process so that we can work with you to meet your needs. Visa mindre

Do you want to join our exciting journey?

We are now looking for a Business Controller to our multicultural team.

As Business Controller your main tasks are to work on financial and business analyses focusing on cost control and act as business and decision support to management at SmartCella group. You will report to the CFO.

Main tasks

- Cost control (business area, projects)
- Monthly report Management
- Quarterly Mgt report to the Board
- Budget/Forecast process
- Oversight of 3rd party accounting provider, Aspia
- Continuous work on enhancing models, processes, and project related tasks


Requirements for the position

- University degree
- >5 years of experience as Business Controller or similar position
- Strong Excel skills
- Experience from Life Science/Pharmaceutical industry and or start-ups is a plus
- Good ability in speech and writing both in Swedish and English


What you need to succeed

We believe you need to have an analytical mind set - attention to details but also ability to see the whole picture, relate to events and make connections and to see patterns and trends. You are responsible, independent, and committed to your work. You have a curious mindset with a passion for continuous learning, continuously seeking information to enable valid questions and challenge the status quo.

You are able to confidently convey messages in a clear and credible manner.

As a person you are organized, structured and drive performance by holding yourself and others accountable.

We are a multicultural team which requires that you have a collaborative approach, good communication skills and actively promote cross-boundary collaboration with the aim of achieving better results.

Interested? Do not hesitate, submit your application today! We will review applications continuously and will fill the position as soon as we have fond the right candidate.



The Smartcella group of companies is focused on developing early-stage biotechnology and medical devices to bring them to the market. The group consists of Procella Therapeutics AB, Smartwise AB, SmartCella Solutions AB and the mother company SmartCella Holding AB.

Procella is a regenerative medicine biotech company focusing on the manufacturing of a cardiac progenitor cell therapy product to treat heart failure. Smartwise is a medical device company developing a novel infusion catheter for precise delivery of drugs and advanced therapeutics and SmartCella Solutions is focused on developing early-stage projects in close collaboration with academia in the field of cell therapy and re-generative medicine. The group strives to bring new therapies and devices to patients in the most safe, efficient, and timely way possible. Visa mindre