Principal Scientist, Aseptic Control – Hybrid MSAT

Vertex Pharmaceuticals Inc (US); United States; Hybrid; USD 146,000 - 218,000; Full time

Benefits offered by this job

Hybrid work arrangement

Job summary

Vertex Pharmaceuticals Inc seeks a Principal Scientist Aseptic Control to lead sterile and low bioburden processing technologies across cell and gene therapy, small molecule, and device programs in cCMP manufacturing.

The role partners with stakeholders to define microbial control strategies, ensures compliance with industry guidance, and interfaces with internal and external sites to support aseptic operations and investigations.

Qualifications

• Degree in biological (microbiology preferred) or engineering.
• 8+ years in biotech/pharma with technical leadership in cGMP facilities.
• Experience with aseptic drug product manufacturing and contamination control.

Responsibilities

• Provide technical input on environmental/facility monitoring deviations to assess batch impact.
• Lead investigations related to aseptic control events.
• Develop risk-based strategies to control bioburden and prevent contamination.
• Support regulatory submissions and pre-approval inspections related to contamination control.
• Collaborate with CDMOs and engineering firms to enable aseptic filling in GMP environments.
• Drive continuous improvement and ensure compliance with regulatory requirements.

Skills

Aseptic processing

GMP

Root cause analysis

Risk-based approaches

Cross-functional leadership

Biologics/ cell therapy

Communication skills

Education

Biological or engineering degree

Job description

Vertex Pharmaceuticals Inc seeks a Principal Scientist Aseptic Control to lead sterile and low bioburden processing technologies across cell and gene therapy, small molecule, and device programs in cCMP manufacturing.

The role partners with stakeholders to define microbial control strategies, ensures compliance with industry guidance, and interfaces with internal and external sites to support aseptic operations and investigations.