Aseptic Control Principal Scientist, MSAT
Vertex Pharmaceuticals
August 08, 2026
Remote friendly (Boston, MA)
United States
Operations
General Summary:
Principal Scientist Aseptic Control provides aseptic/low bioburden processing SME support for cell and gene therapy, small molecule, and combination medical device programs in cCMP manufacturing. Defines microbial control strategies (gowning, facility monitoring incl. EM/water/gases, disinfectant efficacy, aseptic simulations, filtration, particulate control, risk assessments) aligned with industry guidance; supports aseptic/low bioburden investigations and maintains critical cGMP aseptic activities across internal/external sites.
Key Duties and Responsibilities:
- Provide technical input for environmental/facility/process monitoring deviations and contamination events; assess batch impact and drive CAPA.
- Collaborate on aseptic control-related manufacturing investigations.
- Design and implement risk-based contamination control and bioburden strategies for drug substance and drug product sites.
- Support regulatory submissions and pre-approval inspection activities for aseptic operations.
- Partner with process development to implement new aseptic filling technologies for cell therapy drug products in novel device platforms, including with CDMOs and engineering firms.
- Establish post-approval technical stewardship: performance monitoring, troubleshooting, and out-of-conformance resolution with external partners.
- Ensure quality and regulatory compliance; drive operational excellence and continuous improvement.
Knowledge/Skills:
- 10+ years aseptic drug product technical experience in biologics/cell therapy (process development and/or manufacturing).
- Demonstrated risk-based sterility assurance/contamination control best practices; strong communication.
- Deep GMP aseptic processing knowledge; experience with root cause analysis and deviation management.
- Desired: multi-modality drug product support; sterility assurance and facility monitoring program design.
- Problem-solving, urgency, cross-functional collaboration, and staying current with best practices.
Education/Experience:
- Degree in biological (microbiology preferred) and/or engineering disciplines.
- 8+ years in biotech/pharma (ideally technical leadership in a cGMP facility).
Pay Range:
- $145,500 - $218,300
Principal Scientist Aseptic Control provides aseptic/low bioburden processing SME support for cell and gene therapy, small molecule, and combination medical device programs in cCMP manufacturing. Defines microbial control strategies (gowning, facility monitoring incl. EM/water/gases, disinfectant efficacy, aseptic simulations, filtration, particulate control, risk assessments) aligned with industry guidance; supports aseptic/low bioburden investigations and maintains critical cGMP aseptic activities across internal/external sites.
Key Duties and Responsibilities:
- Provide technical input for environmental/facility/process monitoring deviations and contamination events; assess batch impact and drive CAPA.
- Collaborate on aseptic control-related manufacturing investigations.
- Design and implement risk-based contamination control and bioburden strategies for drug substance and drug product sites.
- Support regulatory submissions and pre-approval inspection activities for aseptic operations.
- Partner with process development to implement new aseptic filling technologies for cell therapy drug products in novel device platforms, including with CDMOs and engineering firms.
- Establish post-approval technical stewardship: performance monitoring, troubleshooting, and out-of-conformance resolution with external partners.
- Ensure quality and regulatory compliance; drive operational excellence and continuous improvement.
Knowledge/Skills:
- 10+ years aseptic drug product technical experience in biologics/cell therapy (process development and/or manufacturing).
- Demonstrated risk-based sterility assurance/contamination control best practices; strong communication.
- Deep GMP aseptic processing knowledge; experience with root cause analysis and deviation management.
- Desired: multi-modality drug product support; sterility assurance and facility monitoring program design.
- Problem-solving, urgency, cross-functional collaboration, and staying current with best practices.
Education/Experience:
- Degree in biological (microbiology preferred) and/or engineering disciplines.
- 8+ years in biotech/pharma (ideally technical leadership in a cGMP facility).
Pay Range:
- $145,500 - $218,300