Process Manager Msat

vor 7 Monaten

Basel, Schweiz Skillhubs Vollzeit

Are you ready to make a difference in the lives of patients suffering from severe rare conditions? Do you dream of being part of a biopharma leader that's rewriting the narrative of medical advancement? Look no further - To support our client growth, we are looking for an **Manufacturing Science and Technology (MSAT) expert.**

**Role & Function**

The MSAT team holds the senior scientific and technical knowledge for the manufacturing of clinical and commercial products and is responsible for always keeping the internal and external manufacturing processes in a validated stage.

Department is responsible for optimization and life cycle management of all clinical and commercial manufacturing processes from internal and external network. MSAT ensures compliant, reliable, cost effective and sustainable manufacturing of our products now and in future.

This specific role will take care of **Biological Drug Substance** activities, mainly related to Upstream.

**Key Responsibilities**
- Act as the process owner for Biological DS product validation
- Identify, lead, and execute MSAT projects, including manufacturing process and cost improvement
- Participate in internal activities related to the manufacturing process, such as process changes, major/critical deviations, risk assessments, and CAPAs
- Review, supervise, and document technical studies, qualifications, and validations
- Contribute to the establishment of new analytical specifications and stability programs and review any changes
- Write and review relevant sections of the APR/PQR (Annual Product Review/Periodic Quality Review)
- Ensure continuous process verification (CPV) of products within the assigned area
- Provide input and review relevant sections in registration files, variations, and market expansionSupport the evaluation of new contract manufacturers and participate in the development of supply and quality agreements
- Lead the technical aspects of product transfers, scale-up activities, validations, and oversee the manufacturing processes
- Stay informed about advancements in external biopharmaceutical manufacturing technology, assess their applicability to process innovation, cost reduction, or yield improvement, and introduce relevant new technologies

Contribute to the due diligence process for potential in-sourcing of new products**Profile**
- Master of Equivalent in Chemistry, Biology, Biotechnology, Pharmacy or similar
- +5 years of experience of development and manufacturing of **Biological Drug Substances** for clinical and commercial use
- Recognized expert in biologics drug substance manufacturing
- Demonstrable experience of working in cross functional team with ability to multitask, prioritize and be an effective decision maker.
- Experience of regulatory guidelines, regulatory authorities’ communication and file documentation.
- Lean Management / Agile PM certification highly appreciate
- Fluent in English

**Job Types**: 100%, Permanent

Schedule:

- 8 Hour Shift

Ability to Commute:

- Basel, BS (preferred)

Ability to Relocate:

- Basel, BS: Relocate before starting work (preferred)

Work Location: In person

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