Aseptic Control Principal Scientist, MSAT
Vertex Pharmaceuticals
June 27, 2026
Remote friendly (Boston, MA)
United States
Operations
Key Duties And Responsibilities:
- Provide technical input into environmental/facility/process monitoring deviations and contamination events; assess batch impact and design/implement corrective and preventative actions.
- Collaborate on resolution of manufacturing investigations related to aseptic control events.
- Design and implement risk-based approaches/strategies to control bioburden and prevent contamination for drug substance and drug product manufacturing.
- Support regulatory submissions and pre-approval inspection activities related to aseptic contamination control strategies.
- Partner with process development to design/implement new aseptic filling technologies for cell therapy drug products in novel device platforms, including GMP process/equipment design with CDMOs and engineering firms.
- Establish technical stewardship post-approval: performance monitoring, troubleshooting, and resolution of out-of-conformance events with external contract manufacturing/testing partners.
- Ensure quality/regulatory compliance and drive operational excellence, flawless execution, and continuous improvement.
Qualifications / Knowledge / Skills:
- 10+ years in aseptic drug product technical roles (process development and/or manufacturing) for biologics/cell therapy; demonstrated sterility assurance and contamination control best practices and risk-based approaches.
- Deep understanding of late-phase to commercial GMP aseptically processed drug substance and drug product regulations; strong written/verbal communication.
- Experience with root cause analysis and deviation management.
- Strong understanding of cGMP requirements and technical manufacturing/testing/controls.
- Advanced degree (PhD or equivalent) in biological (microbiology preferred) and/or engineering disciplines; minimum 8 years relevant industry experience, ideally in a technical leadership role in a cGMP facility.
- Influential and current on aseptic processing best practice; participates in industry consortia/conferences.
Compensation:
- Eligible for annual bonus and annual equity awards.
- Provide technical input into environmental/facility/process monitoring deviations and contamination events; assess batch impact and design/implement corrective and preventative actions.
- Collaborate on resolution of manufacturing investigations related to aseptic control events.
- Design and implement risk-based approaches/strategies to control bioburden and prevent contamination for drug substance and drug product manufacturing.
- Support regulatory submissions and pre-approval inspection activities related to aseptic contamination control strategies.
- Partner with process development to design/implement new aseptic filling technologies for cell therapy drug products in novel device platforms, including GMP process/equipment design with CDMOs and engineering firms.
- Establish technical stewardship post-approval: performance monitoring, troubleshooting, and resolution of out-of-conformance events with external contract manufacturing/testing partners.
- Ensure quality/regulatory compliance and drive operational excellence, flawless execution, and continuous improvement.
Qualifications / Knowledge / Skills:
- 10+ years in aseptic drug product technical roles (process development and/or manufacturing) for biologics/cell therapy; demonstrated sterility assurance and contamination control best practices and risk-based approaches.
- Deep understanding of late-phase to commercial GMP aseptically processed drug substance and drug product regulations; strong written/verbal communication.
- Experience with root cause analysis and deviation management.
- Strong understanding of cGMP requirements and technical manufacturing/testing/controls.
- Advanced degree (PhD or equivalent) in biological (microbiology preferred) and/or engineering disciplines; minimum 8 years relevant industry experience, ideally in a technical leadership role in a cGMP facility.
- Influential and current on aseptic processing best practice; participates in industry consortia/conferences.
Compensation:
- Eligible for annual bonus and annual equity awards.