Lediga jobb Sobi i Stockholm

Swedish Orphan Biovitrum ”Sobi” gör betydande skillnad för människor som lever med sällsynta sjukdomar genom innovativa behandlingar. Sobi är ett dynamiskt företag i tillväxt och vi söker nu en HR Business Partner som vill vara med och utveckla företaget och dess medarbetare.

Vi tror på att föra samman människor med olika kompetenser, bakgrunder och idéer i våra projekt. Är du den vi söker?

Som vår HR Business Partner kommer du att stötta cirka 30 chefer, främst i Sverige men också globalt. Tjänsten är placerad på vårt kontor i Solna där du kommer att arbeta med ett team av engagerade, drivna och prestigelösa HR-kollegor.

Du kommer att:

Arbeta brett och proaktivt med både operativt och strategiskt HR arbete där du sätter kunden i centrum.
Coacha och vägleda chefer i deras ledarskap och vardagliga dilemman.
Stötta cheferna med utveckling av deras team på grupp och individnivå.
Bidra med kvalificerat stöd vid rekrytering.
Hantera frågor inom lön & belöning.
Involveras i personalutveckling samt hålla workshops.
Leda fackliga förhandlingar och hjälpa chefer i tolkningar av lagar och avtal.
Vara med och utveckla företagskulturen, ledarskapet och HR-arbetet.


Mer om dig. Du har några års erfarenhet från att jobba operativt och strategiskt i en HR-roll där du alltid har kundens behov i fokus. Vi ser gärna att du har jobbat som HR Business Partner med coachning av chefer, lett förhandlingar och det är ett plus om du har jobbat internationellt samt har kunskap inom learning/leadership.

Du är trygg i dig själv, har lätt för att skapa goda relationer och har ett pragmatiskt arbetssätt. Som person är du engagerad, ödmjuk och ser styrkan i att arbeta i team. Din svenska såväl som engelska är flytande i tal och skrift. Det är ett plus om du har i

Vi erbjuder dig. En utvecklande roll i en internationell verksamhet i tillväxt, där du tillsammans med kollegor jobbar för patientens bästa och där vi till och med kan vara med och rädda liv. Vår kultur kännetecknas av högpresterande team som är engagerade i att hjälpa patienter – våra värderord är Care, Ambition, Urgency, Ownership and Partnership.

Mer om oss. Vi är ett ledande bioteknologiskt läkemedelsföretag inriktat på att tillhandahålla innovativa behandlingar och service, som ger patienter med sällsynta sjukdomar och deras familjer ett bättre liv. Sobi koncentrerar sig på läkemedel för behandling av hemofili, inflammatoriska- och medfödda metabola sjukdomar.

Om du vill veta mer kontakta Josephine Ivstam, rekryteringskonsult, mejl josephine.ivstam@sobi.com. Om du tycker att tjänsten passar in på dig så tveka inte med att söka via länken https://sobi.csod.com/ats/careersite/JobDetails.aspx?site=2&id=1188
dvs  på vår hemsida www.sobi.com
Intervjuer sker löpande så tjänsten kan komma att tillsättas före sista ansökningsdatum. Visa mindre

Senior Clinical Programmer  

The Biostatistics, Data Management and Medical Writing department is looking for a Clinical Programmer to support projects and studies within Immunology and Haematology. The clinical programmer supports the drug development process for new substances, indications and marketing claims in the field of clinical programming.

Key Responsibilities:

Support clinical studies with programming skills.
Responsible for processing of clinical data required for analysis of clinical trials, Phase 1-4.
Develop SAS programs for preparing, processing and analysing clinical data.
Provide input to relevant clinical study documents (e.g. protocol, CRF, SAP, and report).
With deep insight in CDISC data standards and in company- and project needs, often in collaboration with CRO, review and define study data mappings and relevant programming documents.
Support regulatory response documents and other external clinical documents across multiple therapeutics area with analysis and output.
 Support and drive enablement of regulatory submission documents, e.g. define.xml.
Validate work of other programmer/analysts.



Qualifications:
Master of Science (MSc) or Bachelor of Science (BSc) in Computer Science, Mathematics, Statistics, pharmaceuticals Sciences, Life Sciences and related areas.
A minimum of 5 year experience of SAS programming, preferably in the biotechnology/pharmaceutical industry and ideally with a strong understanding of clinical trial data and clinical submissions.
Experience working in a multinational environment and with external service providers (CROs).
Excellent knowledge of SAS programming including application- and macro development skills (Base SAS, Proc , SAS Macro and SAS Graph).
Experience of preparing regulatory submissions in CDISC format (SDTM and ADaM ) is desired.
English, both oral and written communication.



Personal attributes:

Demonstrated ability to work in a team environment (collaborative) as well as to work independently (strong individual initiative).
Strong organisational skills, multi-tasking abilities and a highly developed respect for timelines.
Curiosity and drive to broaden skill and knowledge.


     

Location:

You will be based in Solna, Sweden.

Reporting to:

Mårten Vågerö, Head of Biostatistics, Data Management and Medical Writing, R&D 

For more information:

If you are interested in applying for this position, please submit your CV and cover letter through our web page www.sobi.com please contact:  Mårten Vågerö, marten.vagero@sobi.com, Head of Biostatistics, Data Management and Medical Writing Visa mindre

Sobi is a fast-growing company with an ambitious strategic agenda. With the growth of the company and recent M&A transactions, the Sobi Tax team is faced with new challenges and very interesting opportunities. Sobi is therefore looking to strengthen the Tax team and expanding from currently two to three members. With the right candidate, there will be possibilities to grow with Sobi and tailor the position based on skills and personal interest. We believe that there is a very interesting journey ahead of us to take tax to the next level.
Key Responsibilities:
Manage the Group's tax position
Develop tools and processes for analysis and management of tax risks and opportunities
Support senior management with analyses of complex tax transactions and provide recommendations
Support subsidiaries with tax reporting, local tax matters and Transfer Pricing



Qualifications:
You have at least 5 years’ experience from Transfer Pricing, corporate tax, group tax accounting and reporting
Experience from finance/tax consultancy and/or corporate tax or group accounting
A master's degree in Business, Law or other relevant degree



Personal attributes:
You have the ability to coordinate and lead tax projects
You have an analytic mindset and enjoy working with numbers and analyses
You have the ability to see both details and the bigger picture
You have the ability to take on complex issues and transform them into clear recommendations or actions
You are curious, have a high level of integrity and always look for potential improvements
You are a team-player with strong communication skills
You are fluent in English



Location: The position will be based in Solna, Sweden.
Reporting to:
Erik Krohn, Head of Treasury and Tax, erik.krohn@sobi.com 
For more information:
If you are interested in applying for this position, please submit your CV and cover letter through our web page www.sobi.com  We are interviewing continously. Visa mindre

Sobi IT består av 16 personer som supporterar ca 1 300 användare runt om i världen på våra 14 kontor och vi är representerade i 26 länder. I stort sett all drift sker lokalt på huvudkontoret i Solna. 5 tekniker bemannar vår Servicedesk som har ansvar för våra first och second line ärenden. Sedan har vi idag 4 infrastrukturspecialister med huvudansvar för vår IT-drift och third line support och det är till detta team vi söker en person till. Tillsammans utgör dessa 9 personer Team IT Operations som ska bli 10 personer. Utöver detta team så har vi även Team Architecture, Design & Automation som består av 4 specialister på var sitt område. Båda teamen har var sin chef som i sin tur rapporterar in till Head of IT. ?
Nu söker Sobis IT-avdelning en erfaren IT-tekniker med inriktning mot nätverk med placering på vårt huvudkontor i Solna. VI söker en analytisk och ansvarstagande person som på ett bra sätt bidrar till att vidareutveckla support och drift av vår infrastruktur och våra verksamhetssystem.?
?Arbetsbeskrivning?
Personen ska främst arbeta med förvaltning av nätverk och infrastruktur samt hjälpa ServiceDesk med att lösa problem. ?Arbetsuppgifter som ingår i rollen är:?
Installation, administration och teknisk förvaltning av system och infrastruktur?
Administration och teknisk förvaltning av nätverk?
Konfigurera switchar?
Felsöka nätverksproblem?
Administrera HPEAruba?
Säkerställ IT Säkerhet genom hela infrastrukturen?
Hjälpa och stötta Servciedesk?
Stöd till verksamheten i IT-relaterade frågor?
Identifiera förbättringsområden?
Delta i, utföra eller leda projekt?
Arbeta med validerade system och i valideringsprojekt i enlighet med Sobis kvalitetssystem?



Utbildning och kompetenskrav?
Goda kunskaper i engelska, både tal och skrift?
Dokumenterad erfarenhet av nätverksadministration i större organisationer inom?
HPE och Arbua nätverk?
Aruba WIFI?
Kunskaper inom virtualisering?
Stor erfarenhet av infraastruktur byggt på Microsofts produkter?
Högskoleutbildning eller motsvarande inom IT?
Meriterande – erfarenhet av Azure och O365?
Meriterande – erfarenhet av lagringslösningar gärna Netapp?
Meriterande – Viss programmeringskunskap (Powershell)?
Meriterande – erfarenhet av att jobba med systemvalideringar inom läkemedelsindustrin (Computer Compliance)?



Personliga egenskaper?
Vi söker en analytisk problemlösare som är driven och ansvarstagande och som på ett bra sätt bidrar till att vidareutveckla support och drift av vårt nätverk, infrastruktur samt våra verksamhetssystem.??
Våra värderingar (Care, ambition, urgency, ownership, partnership) genomsyrar vårt dagliga jobb.?



Tjänsten är baserad på vårt huvudkontor i Solna, Stockholm. Vill du veta mer? Kontakta Henrik Anckarsvärd henrik.anckarsvärd@sobi.com
Om du tycker att tjänsten passar in på dig, så tveka inte med att skicka in din ansökan via vår hemsida www.sobi.com
Vi intervjuar fortlöpande. Visa mindre

Sobi is a dynamic and growing company with a high pace of change. This leads to increased demands on IT infrastructure, business support and IT related project. As part of this, Sobi is in the process of utilizing the Microsoft 365 suite to a larger extent. We are therefore now looking for a Microsoft 365 architect to lead and manage this journey, with focus on collaboration. The position is within the IT department at HQ level and will report to the Head of Infra & Architecture. The IT department is managed in-house with 16 FTEs located in Stockholm. 
Main areas of responsibility
 Overall responsible for Microsoft 365 strategy, configuration and implementation
Act as link between IT and the business to gather requirements and translate them into solutions
As as Technical Project Lead for the ongoing Microsoft 365 project, with the goal to better utilize the platform
Manage, maintain and develop Sobi’s collaboration strategy, assessing the different Microsoft offering (SharePoint of different versions, Microsoft Teams, OneDrive) vs other solutions
Lead and manage the migration of data from old to new platforms

Requirements
At least 5-10 years’ experience from working with Microsoft platforms with focus on collaboration
A strategic thinker and problem solver, able to contribute and guide at a senior level but also bringing strong operational skills and a hands-on, “get things done” attitude
Very good understanding of the Microsoft 365 platform in general with significant experience from architecture, design and configurating the platform.
Significant experience working with security settings on Microsoft Azure
Significant experience from SharePoint architecture
Significant experience from working with different collaboration platforms, with focus on Microsoft
Experience from leading projects when migrating to Microsoft 365.
Good communication and presentational skills from planning through execution (written, oral) in both Swedish and English
Strong analytical skills, able to understand complex processes
Pharma Industry experience is considered a plus
Bachelor’s/Master’s degree (or equivalent) in Computer Science, Engineering Science, Management or other related degree

Personal attributes
Our values (Care, Ambition, Urgency, Ownership, Partnership) is the base for our daily work and your professional style should be:
Well-organized, efficient and self-motivated
Demonstrate good interpersonal skills including the ability to interact well with a variety of personalities, geographical, organizational and educational levels.
Ability to work independently, with limited guidance as well as in teams.
Customer oriented

Location
The position is based in our head office in Solna Stockholm, Sweden.
If you would like further information about this position, please contact Jesper Bondesson, mail jesper.bondesson@sobi.com
If you are interested in applying for this position, please submit your CV and cover letter through our home page www.sobi.com
We are interviewing continuously Visa mindre

Do you want to be part of Sobi where we are transforming the lives of people affected by rare disease? Do you want to Lead the management of Pharmacovigilance Agreements (PVA’s) from development to implementation in accordance with relevant procedures?
We are now looking for a Pharmacovigilance Agreements Lead to coordinate development, implementation and compliance monitoring of PVA’s.
Key Responsibilities
Contribute to receipt, tracking, monitoring and documentation of all PVAs
Accountable for ensuring quality, review, compliance and accuracy of all PVAs
Responsible for coordinating activities related to PVAs and ensuring cross functional input to new and existing PVAs
Contribute to development of PVA processes and PVA template(s)
Responsible for communication of contractual commitments to concerned Stakeholders when a PVA becomes effective
Responsible for maintenance of the PV agreements teams site
Provide PVA subject matter expertise during audits and inspections
Qualifications
University level qualification in biosciences or healthcare
At least 3 years’ experience post-graduation in the pharmaceutical industry
Skills & Personal Attributes
Thorough knowledge of regulatory requirements, specially within the European Union
Computer Literate
Fluent in English
Knowledge of following types of agreements: Sales, Commercial, Market Research, Patient Support Programmes, Post Authorisation Non-Interventional programmes / studies, Investigator Sponsored Studies
Strong interpersonal and communication skills
Able to work effectively both independently and collaboratively across the organization
Delivery focus (take initiative and undertake tasks through to completion)
Demonstrated problem solving skills (including taking ownership to ensure timely resolution) with delivery focus and the ability to successfully execute in an environment under time and resource pressures whilst maintaining resilience
Good attention to detail with high quality written outputs, with good organizational abilities (able to establish priorities, schedule activities and meet deadlines) prioritization, and time management proficiencies.
Location: The position will be based in Stockholm, Tomtebodavägen 23 A Solna
Reporting to: Helena Petersen, Drug Safety Operations
For more information: please contact Helena Petersen, helena.petersen@sobi.com
If you are interested in applying for this position, please submit your CV and cover letter using the link below Visa mindre

Drug Safety Physician

SOBI offers the opportunity to work at an international pharmaceutical company focused on specialty pharmaceuticals on fulfilling the high medical needs of rare disease patients and providing treatment and services to them. Our employees have their background in various fields of research, industry and the academic sphere.
We are looking for a Drug Safety Physician who will be involved in all safety surveillance activities for marketed Sobi products and for products under development. The Drug Safety Physician will be responsible for ensuring that safety surveillance activities are conducted to the highest ethical and safety quality standards in compliance with GCP and GVP and worldwide regulatory requirements.
Key Responsibilities:
Ensure ongoing evaluation of the overall safety profile for one or more assigned products, serving as the product safety expert, working in close partnership with assigned Drug Safety Manager (DSM).
Responsible for safety signal management from all sources for assigned products.
Responsible for safety surveillance in clinical studies.
Leads the Benefit Risk Team (BRT) for assigned products.
Leads risk minimization strategies for assigned products.
Provide safety related input to clinical documents and core safety information.
Provide medical safety input during the production and maintenance of Patient Risk Management Plans.
Provide safety related input to preparations for contacts with Health Authorities (HA). Takes part in key meetings at HAs if required.
Maintain knowledge of the company disease and therapeutic areas for marketed drugs and drugs in development.
Interacts with other function ( e.g. Medical Affairs, Clinical Development, Regulatory Affairs, Clinical Translational Science, Quality Assurance/ Quality Control).



Qualifications:
Education/Learning Experience/Work Experience
Required
Medical Doctor with working experience as a physician.
10 years of experience of working in the Pharmaceutical Industry or Drug Regulatory Agency, with at least +5 years of experience in Pharmacovigilance
Experience from Pharmacovigilance work for both marketed products and products under development


Desired: Experience in working at a Drug Regulatory Agency.
Skills/Knowledge/Languages
Required:
In-depth knowledge in pharmacovigilance across all key processes
Knowledge of the Pharmaceutical Industry, especially clinical research and global regulatory requirements.
Fluent in English, both written and oral.

Personal Attributes
Required
Ability to balance medical knowledge with industry standards to achieve business goals.
Service minded and ability to work collaboratively.

Reporting to: This position will be reporting into Head of Safety Science.
If you would like further information about this position please contact Josephine Ivstam Josephine.ivstam@sobi.com
Please apply through the ad on our webpage www.sobi.com Visa mindre

Sobi is looking to recruit a Drug Product Subject Matter Expert (SME) to our Manufacturing, Science and Technology (MS&T) department. MS&T is part of the Global Manufacturing Department, which is responsible for strategies and oversight of clinical, commercial, internal and external manufacturing of Drug Substance, Drug Product and Finished Goods for Sobi projects and products world-wide.
MS&T holds the senior scientific and technical knowledge for the manufacturing of our clinical and commercial products and is responsible for keeping our internal and external manufacturing processes in a validated state. MS&T drives the development and life cycle management for our clinical and commercial manufacturing processes from the internal and external network to ensure compliant reliable, cost effective and sustainable manufacturing of our products.


Job Description
As an SME within MS&T your main responsibilities includes:
- Provide technical and scientific expertise within Drug Product manufacturing.
- Act as SME in deviation investigations, CAPA and Change control
- Provide technical and scientific expertise for primary containers and relevant medical devices
- Be up to date in quality requirements for pharmaceutical products
- Technical and scientific expertise for tech transfers of Sobi drug product manufacturing processes
- Technical and scientific expertise for scale up of Sobi Drug Product processes
- Technical and scientific expertise for validations of Sobi Drug Product processes
- Drive Life Cycle Management for our Drug Product processes to ensure process robustness and continuous optimization.
- Write and/or review manufacturing instructions, annual product quality reviews (APR/PQR), applicable sections in registration files and variations, internal and external SOP´s, qualifications and validations.


Qualifications:
The right candidate fulfills the following qualifications:
- University degree in Chemistry and/or Biotechnology and/or Process Engineering and a minimum of 5 years of experience in the biotech industry
- Experience and in-depth knowledge of Drug Product development and manufacturing of sterile parenteral drugs/biologics and/or enteral drugs
- Experience of both sterile parenteral drugs and enteral drugs is a strong merit
- Experience of Drug Product Process and formulation development and process characterization.
- Experience with Technology transfers
- Experience and knowledge of cGMP manufacturing of biologics and industry regulatory standards.
- Experience of cross functional team work.
- Excellent verbal and written communication skills in English and ability to communicate in a business environment.
- Previous work involving direct contact with CMO´s is a merit. 
- Ability and enjoy working in a volatile environment
- Ability to collaborate with different parties both external and internal
- Highly self-motivated and ability to drive activities


Skills and personal attributes:
To be successful in the role you are driven, flexible and thrive in a role that requires both operational management and strategic overview. You have strong capabilities to analyze complex information or situations and provide sound solutions and to identify, adapt and implement new technologies. You have the ability to work independently and to make priorities in order to deliver business critical items in time. Strong team working skills are required to work effectively and establish/maintain effective working relationships with internal/external partners.


The suitable candidate should demonstrate the Sobi Values; Care for our patients, for our colleagues and for our company, Ambition, Urgency, Ownership and Partnership.


Contact Application & More information.
You will report to Susanne Wood, Head of Manufacturing Science and Technology, contact information susanne.wood@sobi.com
The position is based in Stockholm (Solna or Hornsberg). We will interview candidates continuously with a pause during summer holiday and welcome your application today! If you are interested in applying for this position, please submit your CV and cover letter through our web page www.sobi.com Visa mindre

Sobi is a fast-growing company with an ambitious strategic agenda. With the growth of the company and recent M&A transactions, Treasury is faced with new challenges and very interesting opportunities. Sobi is therefore looking to strengthen the Treasury team. We have taken several steps to develop the organization, processes and infrastructure in Treasury, e.g. we just recently went from having net cash to a substantial net debt, implemented a TMS (Treasury Management System) where there is still interesting challenges in getting further automatization/STP, develop reports and analysis capabilities. We believe that with the right candidate, there will be a very interesting journey ahead of us to take Treasury to the next level.

Key Responsibilities
Manage financial risks, e.g. FX risk and interest rate risk
Manage the Group's net and gross debt, e.g. utilizing cash, existing and new funding sources in the most efficient way
Develop tools, models and reports in TMS for analysis and management of risks, P/L and B/S, liquidity etc.
Support senior management with analyses of complex Treasury transactions and provide recommendations
Support subsidiaries with Treasury matters, infrastructure and internal funding



Qualifications
You have at least 5 years’ experience from either corporate Treasury and/or management Consulting within treasury, with experience from multiple areas within treasury
A master's degree in either Business or Engineering
Experience from designing, implementing and working with a TMS



Personal attributes    
You have an analytic mindset and the ability to take end-to-end responsibility for treasury matters
You are curious, have a high level of integrity and always look for potential improvements
You are a team-player with strong communication skills
You have the ability to take on complex issues and transform them into clear recommendations or actions
You are fluent in English

Location: The position will be based in Sobi HQ in Solna.
Reporting to: Erik Krohn, Head of Treasury and Tax´,  erik.krohn@sobi.com
For more information:
If you are interested in applying for this position, please submit your CV through de add on  our web page www.sobi.com Visa mindre

Sobi is a dynamic and growing company with a high pace of change. This leads to increased demands on IT infrastructure, business support and IT related project. As part of this, Sobi is in the process of utilizing the Microsoft 365 suite to a larger extent. We are therefore now looking for a Microsoft 365 architect to lead and manage this journey, with focus on collaboration. The position is within the IT department at HQ level and will report to the Head of Infra & Architecture. The IT department is managed in-house with 16 FTEs located in Stockholm. Main areas of responsibility Overall responsible for Microsoft 365 strategy, configuration and implementationAct as link between IT and the business to gather requirements and translate them into solutionsAs as Technical Project Lead for the ongoing Microsoft 365 project, with the goal to better utilize the platformManage, maintain and develop Sobi’s collaboration strategy, assessing the different Microsoft offering (SharePoint of different versions, Microsoft Teams, OneDrive) vs other solutionsLead and manage the migration of data from old to new platformsRequirements At least 5-10 years’ experience from working with Microsoft platforms with focus on collaborationA strategic thinker and problem solver, able to contribute and guide at a senior level but also bringing strong operational skills and a hands-on, “get things done” attitudeVery good understanding of the Microsoft 365 platform in general with significant experience from architecture, design and configurating the platform.Significant experience working with security settings on Microsoft AzureSignificant experience from SharePoint architectureSignificant experience from working with different collaboration platforms, with focus on MicrosoftExperience from leading projects when migrating to Microsoft 365.Good communication and presentational skills from planning through execution (written, oral) in both Swedish and EnglishStrong analytical skills, able to understand complex processesPharma Industry experience is considered a plusBachelor’s/Master’s degree (or equivalent) in Computer Science, Engineering Science, Management or other related degreePersonal attributesOur values (Care, Ambition, Urgency, Ownership, Partnership) is the base for our daily work and your professional style should be:Well-organized, efficient and self-motivatedDemonstrate good interpersonal skills including the ability to interact well with a variety of personalities, geographical, organizational and educational levels.Ability to work independently, with limited guidance as well as in teams.Customer orientedLocationThe position is based in our head office in Solna Stockholm, Sweden.If you would like further information about this position, please contact Jesper Bondesson, mail jesper.bondesson@sobi.comIf you are interested in applying for this position, please submit your CV and cover letter through our home page www.sobi.comWe are interviewing continuously Visa mindre

Do you have experience working within Supply Chain Management and want to be part of Sobi, where we are transforming the lives of people affected by rare disease? As a Supply Planning Manager at Sobi you have the overall responsibility to balance supply and demand for assigned products, assuring customer service whilst optimizing site capacity and inventory. You work in close collaboration with a product team and with the objectives to improve defined KPI’s such as Forecast Accuracy, Service Level and Inventory.  No direct report responsibility. The position is in Stockholm. End-to-End (E2E) Supply Planning is accountable for the planning of externally manufactured products through the whole pharmaceutical supply chain, from drug substance (DS), via the manufacturing of the drug product (DP) until delivery of finished goods (FG) to customers. Key ResponsibilitiesThe Supply Planning Manager role within E2E Supply Planning incorporates the following activities:Create an overall E2E supply plan ensuring market demands can be met for the short- and long-term horizon. If the supply and demand plans cannot be balanced the E2E SPM is accountable for the development of options and associated risks and best possible supply to customer. Receive, compile, analyze and communicate forecast updates from market organizations and break down to supply/capacity needs for the different stages to be used for Purchase Order submissions (for FG, DP and DS). Perform annual planning/inventory processes such as LRP (Long Range Planning) and Safety Stock Assessments for a defined assortment. Ensure correct assumptions are applied, perform scenario planning and sign off volume and inventory plans.Responsible for replenishment and inventory management for assigned markets & product, maintaining stock/service levels, COGS accuracy, scrapping and delivery performance. Responsible for defining and monitoring supply chain KPI’s (e.g. Forecast Accuracy) and act when deviations, e.g. Out-Of-Stock situations, thru developing mitigation plans. Responsible for developing, evaluating and maintaining the E2E inventory strategies for FG, DP and DS to ensure supply.Participate in the monthly S&OP process for assigned product families in a standardized manner in line with the global planning calendar to deliver the balanced and executable E2E plan.Develop and improve new or existing supply chain processes within the department’s responsibility. Included in the role is also active work with continuous improvements, general problem solving and process development within the Supply Chain Planning area, with strong focus on cross-functional collaboration.Experience and Required Skills - Master’s degree or equivalent in Supply Chain Management, Logistics, Production Planning or Engineering is preferred, equivalent experience will be considered.- Minimum 3-5 years of experience within a Supply Chain Management environment. - Advanced supply chain planning skills and the understanding of supply chain planning parameters, master data and master data integrity & quality. - Experience working in the following systems: IFS, MS Office, Business Intelligence applications. - Knowledge of Pharmaceutical production supply chain principles, GMP, FDA.- Natural problem-solver with planning skills in combination with a practical mentality  As a person you are effective, proactive and self-driven. You easily collaborate cross functionally. An ability to work in a changing environment and to drive change is also a key factor for this position. You are able to demonstrate behaviors in line with Sobi’s core values: Care, Ambition, Urgency, Ownership and Partnership.Location is in our Head Office; Tomtebodavägen 23 A, Solna.Reporting to Thomas Nilsson, Supply Chain Director. For more information please contact thomas.nilsson@sobi.com Does this sound like the right opportunity for you? Please don’t hesitate to apply, submit your cv and cover letter thorugh our webpage https://sobi.csod.com/ats/careersite/JobDetails.aspx?site=2&id=1073We will interview continuously. Visa mindre

Sobi is looking to recruit an External Manufacturing Manager to our organization responsible for ensuring the steady supply of our products to patients. As an External Manufacturing Manager, you will be responsible for managing third-party contract manufacturing organizations (CMOs) and apply your expertise in the areas of Drug Substance and/or Drug Product cGMP manufacturing, CMO operations and business management. You will be part of a fun experienced team and have the opportunity to share your knowledge and experiences with dedicated co-workers and external partners.Key Responsibilities:External Manufacturing at Sobi is the department responsible for managing the CMO network globally to ensure uninterrupted, reliable and sustainable supply of our products. As an External Manufacturing Manager, you will be responsible and main contact person for Drug Substance and/or Drug Product CMO´s and may lead cross functional product teams in the operational, tactical and strategical space.Main responsibilities include:- Coordinate and drive cGMP manufacturing and uninterrupted supply of drug substance and/or Drug Product at external manufacturers as well as internal activities related to external manufacturing and supply such as, release and delivery, major/critical deviations and CAPAs, process changes and Change control, with support of cross functional product teams.- Be responsible for the business relationship with external drug substance and/or Drug Product manufacturers. This includes being responsible for and coordinating steering committee meetings with CMOs, drive and follow up on KPIs, negotiate and implement amendments and change orders to current supply agreements.- Lead a product team with professionals from e.g. Supply Chain, QA, Manufacturing Support, Manufacturing Science & Technology and Regulatory, ensuring continuous supply to patients by ensuring the right focus of operational activities as well as driving improvements and long-term strategic priorities.- Contribute to writing and/or reviewing manufacturing instructions, annual product quality reviews (APR/PQR), applicable sections in registration files and variations, internal and external SOP´s, qualifications and validations.- On occasions you will be involved in sourcing, tech transfers, scale up and validation of drug substance processes as wells as developing supply and quality agreements.Qualifications:The right candidate fulfills the following qualifications:- University degree in Biotechnology or other relevant scientific fields, and a minimum of 5 years of experience in the biotech industry with experience coupled to drug substance (both up and downstream processing) and/or drug product manufacturing- In-depth knowledge of cGMP manufacturing of biologics and/or small molecule pharmaceuticals and industry regulatory standards.- Previous work involving direct contact with CMO´s is a strong merit.- Excellent verbal and written communication skills in English and ability to communicate in a business environment.Personal attributes:To be successful in the role you are driven, flexible and thrive in a role that requires both operational management and strategic overview. You are analytical and have a problem-solving mindset. You have a strong ability to work independently and to make priorities in order to deliver business critical items in time. Strong team working skills are required to work effectively and establish/maintain effective working relationships with internal/external partners.Location:The position will be based in Hornsberg, Stockholm. We will interview candidates continuously and welcome your application today!.Reporting to:You are reporting to Minna Lundholm Head of External Manufacturing E2E Supply lead Specialty Care, contact information minna.lundholm@sobi.com. For more information:If you are interested in applying for this position, please submit your CV and cover letter through our home page www.sobi.se  jobba här. Visa mindre

Global Manufacturing is responsible for strategies and oversight of clinical, commercial, internal and external manufacturing of Drug Substance, Drug Product and Finished Goods for Sobi projects and products world-wide. The responsibility includes providing leadership and operational excellence of compliant manufacturing operations at internal plants and overseeing the management and delivery from external manufacturers and CMOs, owning and maintaining a cost effective, strategic manufacturing asset network for internal and virtual plants that can meet global health authority requirements and Sobi needs today and in the future, including requirements for new technologies and legislations.External manufacturing is responsible for managing the business relationship with and the manufacturing Drug Substance and Drug Product manufacturing within the Sobi network of Contract Manufacturing Organisations (CMOs).Sobi is looking to recruit an External Manufacturing Director, responsible for leading Business Integration activities, major change projects and cross functional product teams. You will engage with CMOs in terms of business and operations management. You will be part of a fun experienced team and have the opportunity to share your knowledge and experiences with dedicated co-workers and external partners.Key Responsibilities:Participate in or lead business integration activitiesParticipate in or lead major change projectsLead cross functional Product teamsManage CMO business relationshipsQualifications:University degree in Chemistry and/or Biotechnology and/or Process EngineeringAt least 10 years of experience in the pharmaceutical/biotech industryDemonstrated experience of successful management of external suppliers and manufactures and virtual plant network management including extensive negotiation experienceDemonstrated success in managing product SPC/COGS and continuous improvementsExtensive experience of and knowledge of cGMP manufacturing and industry regulatory standardsDemonstrated experience of effective collaborative leadership, managing and developing teams and leadersDemonstrated experience of working in a cross functional matrixed environment and evidence of successful collaboration with internal and external partiesPersonal attributes:Excellent business operational, analytical and strategic planning skillsStrong business drive and negotiation skillsAbility to influence, motivate and collaborate across all functional business lines from shop floor to board roomStrong interpersonal, teamwork, organizational and communication skills: oral/written and listeningAnalytical and have a problem solving mindset.Strong ability to work independently and to make priorities in order to deliver business critical items in time.Demonstrate the Sobi Values; Care for our patients, for our colleagues and for our company, Ambition, Urgency, Ownership and PartnershipLocation:For this position you will be based in Stockholm (Hornsberg) or Basel, Switzerland Reporting to:Minna Lundholm, Head of External Manufacture, contact information minna.lundholm@sobi.com For more information:If you are interested in applying for this position, please submit your CV and cover letter through www.sobi.se . We will interview candidates continuously and welcome your application today! Visa mindre

Do you want to work in a team where you are responsible for establishing Sobis external supply Chains? Sobi is now recruiting a sourcing & purchasing manager. You are providing Strategic Sourcing solutions to support our Project and Product Portfolio. You and your team are also responsible for the supply of a range of products to patients through a network of Contract Manufacturing Organisations (CMOs) as well as managing procurement activities supporting Sobi’s own manufacturing activities. Job Description/Key ResponsibilitiesAssist in facilitating and implementing strategic sourcing decisions taken in the Product Sourcing Council. Manage sourcing of development programmes, clinical and commercial manufacturing and supply related to Drug Substance, Drug Product and Finished Goods, from the External supply (CMO) network.Act as Sourcing representative in Project and Product teams with the responsibility to develop and implement short, medium and long-term sourcing solutions to support advancement of projects from early development into commercialization and Life-cycle management.Develop Request for Information (RFIs) and Request for Proposals (RFPs) and assist in evaluations of proposals and recommendation for supplier selection.Develop and review specifications, statements of work and term sheets.Assist in contract negotiations for technology transfer and development services, manufacturing and supply agreements.Participate and contribute in SRM process as Sourcing/ Procurement representative.Support Sobi’s Internal Manufacturing organization in procurement activities, including establishment and reviews of supply agreements, placing of orders and follow-up of supplier performance.Manage price negotiations and price changes.Provide expertise in inventory management of raw materials for the Internal Manufacture.Work proactively to avoid and resolve delivery issues (Internal Manufacturing). Act as Planner/Buyer for Internal Manufacturing. Assist in implementing Sustainability processes. Report cost savings and or cost avoidance according to Procurement Process. QualificationsYou probably have a university degree (MSc) in Pharmaceuticals, Engineering, Biochemistry or other relevant area and additional qualification in Procurement, Supply chain management and 3 - 5 years of work experience with Strategic Sourcing, supply and procurement with Contract Manufacturing Organizations network, supplier performance and relationship management from Pharma/Biotech industry. To be successful you possess strong business skills and technical skills in areas of: Sourcing and procurement process knowledge and strategy, agreement negotiation and management, developing business cases, supplier analysis and evaluation.    Personal attributesCross-functional and networking abilities and strong teamwork skills are required to work effectively in a project organization and team environment. You have experience of establish/maintain effective working relationships with internal/external partners. You have a high sense of responsibility and can handle both strategic and operational tasks independently, while managing priorities. You are service minded with a large portion of interest in understanding and resolving commercial and technical issues. you are fluent in English OtherThe position is full time. If you find it interesting don’t hesitate to apply and submit your CV and cover letter through our home page www.sobi.se. https://sobi.csod.com/ats/careersite/JobDetails.aspx?site=2&id=945We are interviewing continuously but with a pause during the summer holiday. You will report to Head of Strategic Direct Procurement, Camilla Nyqvist. If you have any questions please contact Camilla Nyqvist, camilla.nyqvist@sobi.com You will be based at our office in Stadshagen, Solna. Visa mindre

Vill du arbeta i ett företag som har patienten i fokus? Gillar du biotekniska processer och att tillverka läkemedel? Då har vi tjänsten för dig. Vi söker nu en processoperatör för tillverkning av proteinläkemedel till kommersiell produktion samt kliniska studier. Du kommer till ett väl sammansvetsat gäng som har roligt på jobbet och som har fokus på kvalité i sitt dagliga arbete. Arbetsuppgifter:Du arbetar i team i produktionen med cellodling och proteinrening. Arbetet består av varierande uppgifter och bedrivs i renrumsmiljö enligt GMP och en del av arbetet utförs via automatiserade processtyrsystem. Det dagliga arbetet utförs självständigt men enligt givna instruktioner och myndighetskrav. Exempel på typiska arbetsuppgifter är: -Hantering av celler från cellbank till produktionsreaktor-Filtrering och gelkromatografi -Bufferttillverkning/mediaberedning och sterilisering -In-processkontroller-Hantering av råvaror -Materialvård såsom disk och autoklavering-Granskning och dokumentationsarbete -Uppdatering av SOPar -Delta i utförande av kvalificeringar -Delta i underhållsarbete Utbildning / Erfarenhet:Vi söker dig som är utbildad läkemedelstekniker alternativt har gymnasieutbildning med processteknisk inriktning eller motsvarande. Även du som har relevant högskoleutbildning med laborativa erfarenheter och är intresserad av produktion kan skicka in din ansökan. Erfarenhet av produktionsarbete inom läkemedelsindustrin räknas som meriterande, tex renrumsarbete, aseptisk arbetsteknik och GMP. Du talar och skriver obehindrat på såväl svenska som engelska. Personliga egenskaper För den här tjänsten lägger vi stor vikt vid personliga egenskaper. Vi söker dig som är noggrann, strukturerad och kvalitetsmedveten. I den här positionen premieras initiativförmåga, samarbetsförmåga och en flexibel inställning till att utföra olika typer av arbetsuppgifter. Vi söker personer som är engagerade och som bidrar med positiv energi till gruppen. Sobis värdegrund är Care, Ambition, Ownership, Urgency och Partnership. Företaget arbetar mot uppsatta mål både på avdelnings- och individnivå. ÖvrigtTjänsten är en tillsvidare anställning på heltid och arbetsplatsen är i Stadshagen på Kungsholmen i Stockholm. Om du tycker att detta känns intressant så tveka inte med att skicka in din ansökan via vår hemsida så snart som möjligt: https://sobi.csod.com/ats/careersite/JobDetails.aspx?site=2&id=935 Vi intervjuar fortlöpande. Vill du veta mer? Kontakta ansvarig chef Linda Redmond, linda.redmond@sobi.com Visa mindre