Sobi seeks a Senior MSAT Technical Lead in Basel to oversee Drug Substance Biologics manufacturing, ensuring technical excellence and regulatory compliance within the Global CMC department.
Positioned within the Global CMC, Science & Technology Department (GCSAT), this role focuses on optimizing and managing the lifecycle of clinical and commercial manufacturing processes. The Technical Lead plays a central part in maintaining high technical standards, ensuring strict regulatory adherence, and driving continuous improvements in production methods across Sobi’s external network.
Responsibilities
- Act as the primary subject matter expert for Drug Substance (DS) Biologics manufacturing.
- Serve as the process owner for DS Biologics validation across Sobi’s product portfolio.
- Lead MSAT initiatives focused on manufacturing process enhancements and cost reduction as part of lifecycle management.
- Manage internal activities regarding external manufacturing, including handling process changes, critical deviations, risk assessments, and corrective actions.
- Draft, review, and approve standard operating procedures (SOPs) and manufacturing instructions.
- Oversee the setup, execution, and documentation of technical studies, qualifications, and validations.
- Contribute to the Annual Product Review (APR) and Product Quality Review (PQR).
- Prepare and review registration documents, variations, and market expansion files, while responding to health authority inquiries.
- Evaluate potential new DS Biologics contract manufacturers and assist in developing supply and quality agreements.
- Lead product transfer and scale-up activities, overseeing manufacturing at external sites for clinical and commercial projects.
- Represent the Science & Technology team in product governance groups, potentially coordinating oversight of DS, DP, and Analytical portfolios.
- Support continuous improvement efforts for internal business processes, systems, and templates.
Requirements
- University degree in Biology, Biotechnology, Pharmacy, or a related field.
- Over 10 years of experience in commercial Drug Substance Biologics manufacturing.
- Extensive background in Upstream Manufacturing, including cell banking and new working cell bank implementation.
- Solid understanding of regulatory guidelines and experience communicating with regulatory authorities.
- Proven ability to work effectively in cross-functional teams, multitask, prioritize, and make decisions.
- Capacity to thrive in unstructured environments and influence outcomes without direct authority.
- Strong initiative and ability to work independently.
- Excellent oral and written communication skills, including active listening.
- Fluency in English.
- Willingness to travel up to 30% of the time.
Nice to have
- Experience in clinical manufacturing and process development for both clinical and commercial stages.
- Background in mammalian cell culture, with bacterial fermentation experience being advantageous.
- Strong knowledge of scale-down models and their qualification.
- Scientific and technical expertise in CMC development and product launch.
What the company offers
- A strong emphasis on maintaining a healthy work-life balance.
- A collaborative and team-oriented work environment.
- Clear opportunities for professional growth and development.
- A commitment to diversity and inclusion within the workplace.
- Competitive compensation packages.
- Comprehensive benefits designed to support staff health and well-being.
About the company
Sobi is a global company with over 1,900 employees across more than 30 countries, dedicated to redefining standards of care for people living with rare diseases. The organization fosters an inclusive, sustainable, and flexible workplace that encourages growth and development. As a diverse team of entrepreneurial individuals, Sobi is passionate about its journey toward becoming a global leader in the biopharmaceutical sector.
- Work that transforms lives and redefines care standards for rare disease patients.
- A diverse, entrepreneurial team focused on global growth.
- An inclusive and flexible workplace culture.
- A global presence committed to local societies.
How to apply
Documents to submit:
Application language: English
Quelle: öffentlich zugängliche Karriereseite des Arbeitgebers. Batchly ist nicht der Arbeitgeber und steht nicht notwendigerweise in einem Vertragsverhältnis mit dem Unternehmen.