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Senior Process Manager MSAT
Location: Stockholm, Sweden or Basel, Switzerland
Company Description
Statistics show that women and underrepresented groups tend to apply to jobs only if they meet 100% of the qualifications. Sobi encourages you to change that statistic and apply. Rarely do candidates meet 100% of the qualifications. We look forward to your application!
At Sobi, the work we do every day redefines the standards of care and transforms the lives of people living with rare diseases. As a diverse team of entrepreneurial people, we are passionate about our growth journey towards becoming a global leader, making a difference for rare disease patients, moving quickly and always challenging the status quo.
We are committed to an inclusive, sustainable and flexible workplace that fosters growth and development.
About the role
As Senior Process Manager MSAT, you will play a pivotal role in ensuring the compliant, reliable, and sustainable manufacturing of Sobi’s clinical and commercial products. You will be part of the Manufacturing Science and Technology (MSAT) team within the Global CMC, Science & Technology Department (GCSAT), contributing your expertise to optimize and manage manufacturing processes across Sobi’s internal and external networks.
This position is based at our Global Headquarters in Stockholm, Sweden or Global hub in Basel, Switzerland, reporting directly to Group Head Aseptics DP.
Key Responsibilities
* Serve as the subject matter expert (SME) for drug product (DP) manufacturing and validation.
* Lead and execute MSAT projects focused on process and cost improvements as part of lifecycle management.
* Participate in activities related to internal and external manufacturing, including process changes, major deviations, risk assessments, and CAPAs.
* Issue, review, and approve internal and external SOPs and manufacturing instructions.
* Oversee the setup, execution, and documentation of technical studies, qualifications, and validations.
* Contribute to the development and review of new product specifications and stability programs.
* Write and review relevant sections of APR/PQR, registration files, variations, and market expansion documents.
* Support the evaluation and onboarding of new DP contract manufacturers, including developing supply and quality agreements.
* Lead technical aspects of product transfers, scale‑up activities, validations, and oversee manufacturing at external partners for clinical and commercial projects.
* Stay informed about advancements in biopharmaceutical manufacturing technology and introduce innovations that drive process improvement, cost reduction, or yield enhancement.
Qualifications
You are a driven and collaborative professional with a passion for advancing biopharmaceutical manufacturing. You thrive in dynamic, cross‑functional environments and are motivated by the opportunity to make a meaningful impact for patients with rare diseases. You are committed to continuous learning, embrace new technologies, and are eager to contribute to a culture of innovation and excellence. Your strong communication skills, ability to act independently, and dedication to Sobi’s core values—Care, Ambition, Urgency, Ownership, and Partnership—set you apart.
Key Qualifications
* University degree in Chemistry, Biology, Biotechnology, Pharmacy, or a related field.
* At least 5 years of experience in the development and manufacturing of drug products (DP) for clinical and commercial use.
* Deep scientific and technical expertise in CMC development and aseptic drug product manufacturing.
* Recognized as an expert in aseptic drug product manufacturing.
* Demonstrated experience working in cross‑functional teams, with the ability to multitask, prioritize, and make effective decisions.
* Strong knowledge of regulatory guidelines, experience in communication with regulatory authorities, and proficiency in preparing regulatory documentation.
* Fluent in English, with excellent oral and written communication skills.
Additional Information
Here at Sobi we live by our core values: Care, Ambition, Urgency, Ownership, and Partnership.
How to apply
We have an ongoing selection process in this recruitment and ask you to send your application as soon as possible. Click apply and include your resume in English.
Why Join Us?
* Emphasis on work/life balance
* Collaborative and team‑oriented environment
* Opportunities for professional growth
* Diversity and inclusion
* Competitive compensation for your work
* Making a positive impact to help ultra‑rare disease patients who are in need of life‑saving treatments
Other Details
Seniority level: Mid‑Senior level
Employment type: Full‑time
Job function: Science
Industries: Pharmaceutical Manufacturing
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