Senior Aseptic Control Scientist, MSAT Process (Hybrid)

Vertex Pharmaceuticals Incorporated; Boston (MA); Hybrid; USD 146,000 - 218,000; Full time

Benefits offered by this job

Hybrid work arrangement

Job summary

Vertex Pharmaceuticals Incorporated is seeking a Principal Scientist Aseptic Control based in Boston, MA, hybrid eligible. You will lead aseptic processing strategies for cell and gene therapy, small molecule, and device programs, ensuring regulatory compliance and collaboration with internal and external sites.

The role requires deep expertise in aseptic processing, sterility assurance, and contamination control, with a track record across GMP environments and cross-functional teams.

Qualifications

• Extensive aseptic drug product experience in biotech/pharma, with leadership in GMP environments.
• Strong knowledge of sterility assurance and contamination control practices.
• Experience supporting regulatory submissions and inspections for aseptic operations.

Responsibilities

• Provide input on deviations and contamination events to protect batch disposition.
• Collaborate to resolve manufacturing investigations related to aseptic control.
• Design risk-based strategies to control bioburden for drug substance and product manufacturing sites.
• Support regulatory submissions and pre-approval inspections for contamination control.

Skills

Aseptic processing

GMP compliance

Cell & Gene Therapy

Process development

Root cause analysis

Troubleshooting

Regulatory submissions

Deviations management

Cross-functional collaboration

Risk-based approaches

Education

Biology degree

Engineering degree

Job description

Vertex Pharmaceuticals Incorporated is seeking a Principal Scientist Aseptic Control based in Boston, MA, hybrid eligible. You will lead aseptic processing strategies for cell and gene therapy, small molecule, and device programs, ensuring regulatory compliance and collaboration with internal and external sites.

The role requires deep expertise in aseptic processing, sterility assurance, and contamination control, with a track record across GMP environments and cross-functional teams.