MSAT Project Lead

BioTalent; Basel; Vor Ort; CHF 180.000 - 240.000; Vollzeit

Zusammenfassung

BioTalent is seeking an experienced MSAT Technical Lead for Drug Substance Biologics in Switzerland or remote. You will provide technical leadership across manufacturing process validation, technology transfers, lifecycle management, regulatory support, and external manufacturing oversight for commercial and clinical biologics.

The role requires a strong background in mammalian cell culture and MSAT, with hands-on process validation, tech transfers, deviations and CAPAs, and collaboration across

Qualifikationen

• 10+ years in commercial biologics drug substance manufacturing
• Strong MSAT and technical operations experience
• Experience supporting external manufacturing organisations
• Hands-on mammalian cell culture experience
• Experience with cell banking and working cell bank implementation
• Experience leading validation activities for biological products
• Technology transfer and scale-up experience
• Experience managing deviations, CAPAs and change controls
• Regulatory submission support and health authority interaction experience

Aufgaben

• Act as SME for DS Biologics manufacturing processes
• Process owner for DS Biologics validation activities
• Lead MSAT projects focused on process optimisation, yield enhancement and cost reduction
• Drive process changes, investigations, deviations, risk assessments and CAPAs
• Review and approve SOPs, manufacturing instructions and technical documentation
• Oversee technical studies, process validations and qualification activities
• Contribute to APR/PQR preparation and review
• Support CMC regulatory submissions and health authority responses
• Assess and support onboarding of new biologics CMOs/CDMOs
• Lead technology transfers, scale-up activities and commercial manufacturing implementations
• Monitor manufacturing performance and recommend process improvements
• Introduce innovative technologies to improve manufacturing efficiency
• Represent MSAT/SAT in governance forums and cross-functional project teams
• Support continuous improvement across systems, processes and templates

Kenntnisse

MSAT expertise

Technical operations

External manufacturing

Mammalian cell culture

Ausbildung

Biotechnology/Biological sciences degree

Jobbeschreibung

Job Title: MSAT Technical Lead (DS Biologics)

Location: Switzerland or Remote

Duration: ASAP until 31 December 2026

FTE: 100%

Travel: Up to 30%

Our client is seeking an experienced MSAT Technical Lead with deep expertise in Drug Substance (DS) Biologics manufacturing to support commercial and clinical biologics operations. The successful consultant will provide technical leadership across manufacturing process validation, technology transfers, lifecycle management initiatives, regulatory support, and external manufacturing oversight.

This role requires a strong scientific background in biologics manufacturing, particularly mammalian cell culture, and extensive experience within MSAT, technical operations, process validation, and external manufacturing environments.

Key Responsibilities

• Act as SME for DS Biologics manufacturing processes.


• Serve as process owner for DS Biologics validation activities.


• Lead MSAT projects focused on process optimisation, yield enhancement and cost reduction.


• Drive process changes, investigations, major deviations, risk assessments and CAPAs.


• Review and approve SOPs, manufacturing instructions and technical documentation.


• Oversee technical studies, process validations and qualification activities.


• Contribute to APR/PQR preparation and review.


• Support CMC regulatory submissions, variations and health authority responses.


• Assess and support onboarding of new biologics CMOs/CDMOs.


• Lead technology transfers, scale-up activities and commercial manufacturing implementations.


• Monitor manufacturing performance and recommend process improvements.


• Introduce innovative technologies supporting manufacturing efficiency and robustness.


• Represent MSAT/SAT in governance forums and cross-functional project teams.


• Support continuous improvement initiatives across systems, processes and templates.

Required Qualifications

Education

• Degree in Biotechnology, Biology, Pharmacy, Biochemical Engineering or related scientific discipline.

Experience

• 10+ years of experience in commercial biologics drug substance manufacturing.


• Strong MSAT and technical operations experience.


• Extensive experience supporting external manufacturing organisations.


• Hands-on experience with mammalian cell culture.


• Experience with cell banking and working cell bank implementation.


• Experience leading validation activities for biological products.


• Technology transfer and scale-up experience.


• Experience managing manufacturing deviations, CAPAs and change controls.


• Regulatory submission support and health authority interaction experience.

Preferred Experience

• Clinical manufacturing experience.


• Bacterial fermentation knowledge.


• Scale-down model development and qualification.


• Product launch and CMC development experience.