3 days ago

Director of Manufacturing Science and Technology (Based in Stockholm, Basel or Geneva)

Swedish Orphan Biovitrum AG

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At Sobi, we are transforming the lives of people affected by rare diseases. As a specialized international biopharmaceutical company based in Sweden, we provide sustainable access to innovative therapies in the areas of hematology, immunology and specialty care. We bring something rare to rare diseases.

Sobi has three premises in Switzerland: an office and R&D laboratory in Geneva; a sales office in Lucerne; and a newly opened office in Basel hosting both local and global staff. Sobi AG has around 150 employees in Switzerland, working with immunology research and development, and support for patients and healthcare professionals. You can find more information about Sobi at www.sobi.com.

Sobi is seeking to recruit a Head of Manufacturing Science and Technology (MS&T) based either in Stockholm, Geneva or Basel.

MS&T is part of the Global Manufacturing department of Technical Operations at Sobi. MS&T is the powerhouse of manufacturing science and technology and ensures scientific oversight of Sobi’s clinical and commercial manufacturing processes from both internal and external network. MS&T drives optimization and life cycle management of our manufacturing processes and ensures compliant, reliable, cost-effective and sustainable manufacturing of our products, now and in the future. MS&T is a relatively newly formed team made up of experienced and dedicated personnel. The MS&T team is currently primarily based in Stockholm. The incumbent will report  to the Head of Global Manufacturing.  

Director of Manufacturing Science and Technology (Based in Stockholm, Basel or Geneva)

At Sobi, we are transforming the lives of people affected by rare diseases. As a specialized international biopharmaceutical company based in Sweden, we provide sustainable access to innovative therapies in the areas of hematology, immunology and specialty care. We bring something rare to rare diseases.

Sobi has three premises in Switzerland: an office and R&D laboratory in Geneva; a sales office in Lucerne; and a newly opened office in Basel hosting both local and global staff. Sobi AG has around 150 employees in Switzerland, working with immunology research and development, and support for patients and healthcare professionals. You can find more information about Sobi at www.sobi.com.

Sobi is seeking to recruit a Head of Manufacturing Science and Technology (MS&T) based either in Stockholm, Geneva or Basel.

MS&T is part of the Global Manufacturing department of Technical Operations at Sobi. MS&T is the powerhouse of manufacturing science and technology and ensures scientific oversight of Sobi’s clinical and commercial manufacturing processes from both internal and external network. MS&T drives optimization and life cycle management of our manufacturing processes and ensures compliant, reliable, cost-effective and sustainable manufacturing of our products, now and in the future. MS&T is a relatively newly formed team made up of experienced and dedicated personnel. The MS&T team is currently primarily based in Stockholm. The incumbent will report to the Head of Global Manufacturing.

Key responsibilities

The Head of MS&T is responsible for managing the MS&T department. The future incumbent will :

  • Build up and establish the structure for this new function in Global Manufacturing and thus ensure that the MS&T department is run according to industry best practice.

  • Lead the MS&T team, develop team members, build and maintain a high-performing team of experienced and engaged co-workers.

  • Ensure that team members have the relevant in-depth senior scientific and technical expertise regarding manufacturing of Drug Substance/API, Drug Product (including container closure and device), Finished Goods and IMP to ensure reliable and sustainable delivery of clinical and commercial products, now and in the future. The team's responsibility includes both biologic and small molecule products.

  • Make sure that team members have the cGMP know-how and uphold relevant expertise of current and future legislation, while maintaining Sobi's internal and external processes in a compliant and validated state

  • Be accountable for the efficient leadership of life cycle management of our clinical and commercial processes and uphold and deliver on strategic plans to ensure process robustness as well as supporting sustainable SPC/COGS development for our products within internal and external network.

  • Be responsible for maintaining efficient and senior SME support for complex Drug Substance/API, Drug Product, Finished Goods and IMP manufacturing issues, changes, transfers and validations (biologics and small molecules).
  • Be Responsible for ensuring efficient scientific support for continuous process verifications and process data trending reviews
  • Ensure ownership and support for CMC regulatory file documentation for initial applications, variations and new market entries. Be responsible for strategic oversight of the CMC regulatory files for our products.

 

Skills and Competencies

  • A PhD is required in chemistry, biotechnology, process engineering or in any close related field. A second-level University degree can be accepted in lieu of the PhD with 5 additional years of relevant experience.

  • At least 10 years of experience in the pharmaceutical/biotech industry are required.

  • Strong scientific and technical background from CMC development and manufacturing of Drug Substance, API and Drug Product is required.

  • Good knowledge of cGMP manufacturing and industry regulatory standards

  • In-depth knowledge of biologics manufacturing and experience of API/small molecule manufacturing and Finished Goods and IMP manufacturing would be a strong asset.

  • Proven track record of effective collaborative leadership, managing and developing teams and leaders

  • Experience in building and implementing new organisations and structures

  • Experience in working in a global and cross-functional matrixed environment and evidence of successful collaboration with internal and external parties

  • Experience in working with CMOs would be an advantage

  • Accountable, goal-oriented, ability to act independently and take the initiative with a can-do attitude

  • Engaging and strong interpersonal skills, organizational and communication skills and cross-functional collaboration skills

  • Ability to act, engage and deliver in a changing environment

  • Analytical thinker and scientifically driven when required

  • Fluency in English is required.

     

The suitable candidate will embody Sobi's values: Care for our patients, for our colleagues and for our company, Ambition, Urgency, Ownership and Partnership.

 

Location:

The position is preferably based at Sobi's global HQ in Stockholm. However, Geneva or Basel can also be considered as possible locations for this position.

 

Additional information:

For more information, please contact Josephine Ivstam Josephine.Ivstam@sobi.com

If you are interested in applying for this position, please visit www.sobi.com /careers/current vacancies and apply online to the Director of Manufacturing Science and Technology position or click on : https://sobi.csod.com/ats/careersite/JobDetails.aspx?site=2&id=1182

 

Submit your CV and cover letter in English using the "Apply now" button on the left-hand side of the screen. Candidates will be interviewed on a continuous basis. You are welcome to send in your application today!

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