MSAT Manager

Barrington James; Zürich; Vor Ort; CHF 180.000 - 240.000; Vollzeit

Zusammenfassung

Barrington James is seeking an experienced Senior Manager, MSAT - Drug Substance to provide technical leadership across the Drug Substance lifecycle for a global pharmaceutical organisation. The role focuses on Upstream Processing (USP) in commercial biologics and spanning development through to manufacturing; experience across cell banking, DSP and lifecycle management is highly valued.

The successful candidate will act as a senior SME, driving technology transfer, process validation, and

Qualifikationen

• Experience leading USP process development and tech transfer in commercial biologics.
• Strong knowledge of GMP, QA/QC interfaces and regulatory expectations.
• Demonstrated leadership of scientists and engineers in a matrix organisation.

Aufgaben

• Provide technical leadership for Drug Substance manufacturing with emphasis on USP.
• Lead tech transfer, scale-up, process validation and industrialisation of biologics processes.
• Oversee investigations, deviations, CAPAs and process improvements in commercial campaigns.
• Act as senior SME for USP including cell culture, bioreactor operations, scale-up and process robustness.
• Support CPV, process monitoring and lifecycle activities across sites.
• Lead cross-functional projects with Manufacturing, Quality, Process Development and Regulatory.

Kenntnisse

Upstream Processing (USP)

Technology Transfer

Process Validation

GMP / cGMP

Biologics Manufacturing

Leadership

Regulatory Liaison

Cross-functional Collaboration

Ausbildung

Bachelor's or Master's in Biotechnology/Biochemistry/Chemical Engineering/Bioprocess Engineering/Biological Sciences

PhD (advantageous)

Jobbeschreibung

Location: France / Switzerland / Germany Function: Manufacturing Science & Technology (MSAT) Level: Senior Manager Industry: Global Pharmaceutical / Biopharmaceutical

The Opportunity

We are seeking an experienced Senior Manager, MSAT - Drug Substance to provide technical and strategic leadership across the Drug Substance manufacturing lifecycle for a global pharmaceutical organisation.

The role will sit within the global MSAT organisation and will act as a key technical interface between Process Development, Manufacturing, Quality, Engineering, Regulatory and global technical functions.

The successful candidate will bring strong expertise in Upstream Processing (USP) within commercial biologics manufacturing, with experience supporting processes from early development and technology transfer through to validation, commercial manufacturing and lifecycle management.

Experience across cell banking, upstream and downstream processing would be highly advantageous.

Key Responsibilities

• Provide technical leadership for Drug Substance manufacturing, with particular expertise in Upstream Processing (USP).
• Lead and support the technology transfer, scale-up, process validation and industrialisation of biologics manufacturing processes.
• Provide technical oversight and troubleshooting support for commercial manufacturing campaigns, including investigations, deviations, CAPAs and process improvements.
• Act as a senior technical SME for USP process science, including cell culture, bioreactor operations, process parameters, scale-up and process robustness.
• Ideally provide expertise across the cell banking -> USP -> DSP -> Drug Substance lifecycle.
• Support process characterisation, continued process verification (CPV), process monitoring and lifecycle management activities.
• Lead cross-functional technical projects involving Manufacturing, Quality, Engineering, Process Development and Regulatory.
• Drive continuous improvement initiatives focused on process robustness, yield, productivity, reliability and manufacturing performance.
• Support new product introductions, manufacturing transfers and implementation of process changes across manufacturing sites.
• Provide technical input into regulatory submissions, validation documentation, technical reports and responses to regulatory authorities.
• Lead complex technical investigations and root-cause analysis, translating process data into practical manufacturing improvements.
• Establish and maintain strong relationships with internal manufacturing sites, external partners and global MSAT teams.
• Develop and mentor MSAT scientists and engineers, providing technical and scientific leadership within a matrix organisation.
• Contribute to the development of global Drug Substance MSAT strategy, standards and best practices.
• Strong experience within biopharmaceutical / biologics manufacturing.
• Strong understanding of Drug Substance manufacturing and GMP operations.
• Experience with technology transfer, scale-up, process validation and manufacturing support.
• Experience leading technical investigations, troubleshooting and process improvement.
• Strong understanding of cGMP and pharmaceutical regulatory requirements.
• Proven experience working cross-functionally within a complex pharmaceutical environment.

Highly desirable:

• Experience with cell banking / cell bank characterisation and management.
• Experience across both USP and DSP.
• Mammalian cell culture / bioreactor experience.
• Fed-batch and/or perfusion processes.
• Process characterisation and CPV.
• PAT / process monitoring.
• Experience supporting PPQ and commercial launches.
• Experience working across multiple manufacturing sites or within a global MSAT network.
• Previous experience within a global pharmaceutical or large biopharmaceutical organisation.

Leadership Profile

We are looking for an individual who can operate as both a technical expert and senior leader.

You will be comfortable moving between detailed process science and senior-level strategic discussions, with the ability to influence stakeholders without relying solely on direct authority.

The ideal candidate will demonstrate:

• Strong technical credibility within biologics Drug Substance.
• Proven leadership of scientists, engineers or technical teams.
• Excellent stakeholder management and communication skills.
• Experience operating within a matrix/global organisation.
• Strong project and programme leadership capabilities.
• A data-driven and problem-solving approach.
• Ability to influence decisions across Manufacturing, Quality, R&D and Technical Operations.
• A pragmatic, hands-on approach to solving manufacturing challenges.
• Experience & Education
• Bachelor's or Master's degree in Biotechnology, Biochemistry, Chemical Engineering, Bioprocess Engineering, Biological Sciences or a related discipline.
• PhD would be advantageous.
• Typically 8-12+ years' relevant experience within biopharmaceutical manufacturing, MSAT, process development or technical operations.
• Demonstrated experience in commercial biologics Drug Substance manufacturing.
• Previous people-management or technical leadership experience.

Location

The position can be based at a suitable France, Switzerland or Germany location, depending on the successful candidate and site requirements.

Candidates currently working in major European biopharma hubs, including Basel, Zurich, Solothurn, Visp, Frankfurt, Munich and major French biopharma manufacturing locations, would be of particular interest. There are strong precedents for this type of role in Switzerland and Germany; for example, Biogen's Solothurn organisation has recruited senior MSAT leadership specifically around USP process transfer, validation and commercial Drug Substance manufacturing.

Why Join?

This is an opportunity to join a global MSAT organisation with direct influence over commercial Drug Substance manufacturing, technology strategy and the long-term robustness of biologics production.

The successful candidate will have the opportunity to operate at the intersection of science, manufacturing and global technical strategy, influencing products and processes across the full Drug Substance lifecycle.