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.
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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.
