Senior Process Manager MS&T

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.