MSAT Bio DS Process Lead

Location: Bulle, Switzerland

Activity rate : 100%

Type of contract: Temporary contract (until 30.09.2026 with a possible extension)

Start Date: ASAP

End Date: 30.09.2026

We are looking for a dedicated MSAT Bio DS Process Specialist to be based in our manufacturing site in Bulle, Switzerland.

As an MSAT Bio DS Process Specialist, you will play a pivotal role in the development and optimization of downstream processes for biologics. Your responsibilities will include ensuring process scalability, troubleshooting production issues, and collaborating with cross-functional teams to enhance process efficiency and product quality. This position requires a strong understanding of bioprocessing principles and hands-on experience with downstream processing techniques.

Your key responsibilities:

• Support Process Tech Transfers: facilitate the transfer of microbial biotechnological manufacturing processes from development to internal manufacturing and CMOs, ensuring successful commercial-scale process validation and transitions between commercial plants.
• Support Tech Transfer Activities: write risk assessments and protocols, coordinate sampling and analyses, and ensure adherence to project planning in collaboration with Quality Assurance, Industrial Leads, and other stakeholders.
• Process Validation Support: define validation strategies, conduct risk assessments, write validation plans and reports, and ensure adherence to applicable documents for microbial biotechnological manufacturing processes.
• Collaboration and Expertise: liaise with development teams, participate in deviations and Change Controls, collaborate with MSAT Lab and Process Leads, and lead improvement projects, providing process expertise where needed.
• Compliance and Training: work according to cGMP requirements, complete all required trainings within deadlines, and ensure the use of authorized documents for all activities.
• Support CPV implementation: assist with Continued Process Verification for new processes and help manage routine data trending.
• Provide operational support: deliver first and second-line troubleshooting for manufacturing campaigns and CMO partners.
• Facilitate process optimization: monitor commercial manufacturing to identify improvement and COGS reduction opportunities.
• Maintain technical documentation: ensure process documentation is up-to-date for approved and commercial processes.
• Support regulatory readiness: help prepare for Health Authority (HA) inspections and support Prior Approval Supplement (PAS) submissions.