Overview
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.
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.
Qualifications
What will make you successful:
Master's degree or Engineering degree in Biology, Biotechnology, or a related Life Sciences field.
Proven and confirmed experience in the biotech industry within similar roles (pharma experience is also valued).
High understanding of biotechnological manufacturing processes, with Tech Transfer experience as a major asset.
Fluent in both English and French (written and verbal), both are mandatory.
High level of autonomy and curiosity, with a focus on the precise application of established processes.
Ability to scope, research, and understand complex technical subjects related to biotech manufacturing.
Pragmatic and critical-minded with a strong sense of responsibility, ownership, and initiative.
Proficient with MS Office tools, specifically Word and Excel.
Excellent organization and problem-solving skills, with the ability to structure ideas quickly and clearly.
Comfortable managing priorities and staying solution-oriented in a fast-paced environment.
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