Jobdescription
Location: Bulle, Switzerland
Activity rate : 100%
Type of contract: Temporary contract
Start Date: ASAP
End Date: 30.09.2026 (with a possible extension)
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.
Qualifikationen
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.