Senior Process Manager MS&T

Senior Process Manager MS&T

Sobi

Stockholm or Basel

Job Description

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

About you

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.