About the Role:
We are seeking an experienced MSAT Specialist with strong technical expertise in Upstream and Downstream processing, particularly in cell culture-based biomanufacturing. The ideal candidate will play a key role in supporting technology transfer, process optimization, and troubleshooting for large-scale biologics manufacturing.
Key Responsibilities:
- Support technology transfer of upstream (cell culture) and downstream (purification) processes from development to GMP manufacturing.
- Provide technical input during process scale-up, validation, and routine manufacturing campaigns.
- Troubleshoot and resolve process deviations, working closely with manufacturing, QA, QC, and engineering teams.
- Participate in process risk assessments, root cause investigations, and implementation of CAPAs.
- Develop and review technical documentation, including batch records, SOPs, protocols, and reports.
- Drive process improvement initiatives to improve yield, robustness, and scalability.
- Ensure alignment with GMP, ICH, and regulatory expectations during MSAT activities.
- Specialist for upstream cell culture processes (e.g. bioreactors, media prep) and/or downstream purification (e.g. chromatography, UF/DF).
Requirements:
- Degree in Biotechnology, Bioprocess Engineering, Life Sciences, or related field.
- Minimum 5 years of hands-on experience in MSAT, with exposure to both upstream and downstream processes in a GMP environment.
- Strong understanding of cell culture operations, bioreactor systems, purification platforms, and biologics production workflows.
- Familiar with GMP, cGMP, ICH Q8–Q10, and tech transfer best practices.
- Proven ability to work cross-functionally in a fast-paced, regulated manufacturing environment.
- Strong problem-solving and technical writing skills.