Aseptic Control Principal Scientist, MSAT
Vertex Pharmaceuticals
August 29, 2026
Remote friendly (Boston, MA)
United States
Operations
General Summary:
Principal Scientist Aseptic Control provides sterile and low bioburden processing expertise and technical support for cGMP manufacturing of cell and gene therapy (C>), small molecule, and combination medical device programs. Partners with stakeholders to define microbial control strategies (gowning, facility monitoring programs such as EM/water/gases, disinfectant efficacy, aseptic simulations, filtration, particulate control, and risk assessments) and ensures alignment with industry guidance. Interfaces with internal and external manufacturing sites and supports investigations involving aseptic and/or low bioburden processing and facility monitoring.
Key Duties And Responsibilities:
- Provide technical input into environmental/facility/process monitoring deviations and contamination events; determine impact to batch disposition and design/implement CAPAs.
- Collaborate on resolution of manufacturing investigations related to aseptic control events.
- Design and implement risk-based strategies to control bioburden and prevent contaminations for drug substance and drug product manufacturing sites.
- Support regulatory submissions and pre-approval inspection activities related to contamination control.
- Partner with Process Development to implement new aseptic filling technologies for cell therapy in novel device platforms with CDMOs and engineering firms.
- Establish technical stewardship of control strategies post-approval, including performance monitoring and troubleshooting/out-of-conformance resolution.
- Adhere to a culture of quality and ensure documentation meets regulatory requirements; align with global Health Authority expectations.
- Drive operational excellence, flawless execution, and continuous improvement.
Knowledge and Skills:
- 10+ years in aseptic drug product process development and/or manufacturing for biologics/cell therapy.
- Implement industry best practices and risk-based sterility assurance/contamination control.
- Deep understanding of late phase to commercial GMP aseptic manufacturing regulations; excellent communication.
- Desired: experience across multiple sterile modalities and facility monitoring program design.
- Experience with root cause analysis and deviation management.
- Strategic, results-oriented, ethical, and hands-on problem solver.
Education And Experience:
- Degree in biological (microbiology preferred) and/or engineering disciplines.
- At least 8 years relevant biotech/pharma experience, ideally technical leadership in a cGMP facility.
Pay Range: $145,500 - $218,300
Eligible for annual bonus and annual equity awards (and possibly overtime per federal/state requirements).
Application Instructions:
Contact Talent Acquisition at ApplicationAssistance@vrtx.com for hiring-process accommodation needs.
Principal Scientist Aseptic Control provides sterile and low bioburden processing expertise and technical support for cGMP manufacturing of cell and gene therapy (C>), small molecule, and combination medical device programs. Partners with stakeholders to define microbial control strategies (gowning, facility monitoring programs such as EM/water/gases, disinfectant efficacy, aseptic simulations, filtration, particulate control, and risk assessments) and ensures alignment with industry guidance. Interfaces with internal and external manufacturing sites and supports investigations involving aseptic and/or low bioburden processing and facility monitoring.
Key Duties And Responsibilities:
- Provide technical input into environmental/facility/process monitoring deviations and contamination events; determine impact to batch disposition and design/implement CAPAs.
- Collaborate on resolution of manufacturing investigations related to aseptic control events.
- Design and implement risk-based strategies to control bioburden and prevent contaminations for drug substance and drug product manufacturing sites.
- Support regulatory submissions and pre-approval inspection activities related to contamination control.
- Partner with Process Development to implement new aseptic filling technologies for cell therapy in novel device platforms with CDMOs and engineering firms.
- Establish technical stewardship of control strategies post-approval, including performance monitoring and troubleshooting/out-of-conformance resolution.
- Adhere to a culture of quality and ensure documentation meets regulatory requirements; align with global Health Authority expectations.
- Drive operational excellence, flawless execution, and continuous improvement.
Knowledge and Skills:
- 10+ years in aseptic drug product process development and/or manufacturing for biologics/cell therapy.
- Implement industry best practices and risk-based sterility assurance/contamination control.
- Deep understanding of late phase to commercial GMP aseptic manufacturing regulations; excellent communication.
- Desired: experience across multiple sterile modalities and facility monitoring program design.
- Experience with root cause analysis and deviation management.
- Strategic, results-oriented, ethical, and hands-on problem solver.
Education And Experience:
- Degree in biological (microbiology preferred) and/or engineering disciplines.
- At least 8 years relevant biotech/pharma experience, ideally technical leadership in a cGMP facility.
Pay Range: $145,500 - $218,300
Eligible for annual bonus and annual equity awards (and possibly overtime per federal/state requirements).
Application Instructions:
Contact Talent Acquisition at ApplicationAssistance@vrtx.com for hiring-process accommodation needs.