Aseptic Control Principal Scientist — MSAT (Hybrid)

Vertex Pharmaceuticals LLC; Boston (MA); Hybrid; USD 145,000 - 218,000; Full time

Job summary

Vertex Pharmaceuticals LLC in Boston, MA seeks a Principal Scientist Aseptic Control with expertise in sterile and low bioburden processing technologies for cell & gene therapy and biologics. The role partners with stakeholders to define microbial control strategies and ensure cGMP compliance across sites, including CDMOs and engineering firms.

The incumbent will lead investigations, develop risk-based approaches for contamination control, and support regulatory submissions in a GMP

Qualifications

• 8+ years of experience in biotech or pharmaceutical industries, ideally in a technical leadership role in a cGMP facility.
• Demonstrated ability to implement industry-recognized best practices and risk-based approaches for sterility assurance and contamination control and prevention.
• Excellent written and verbal communication skills with ability to work across functions.

Responsibilities

• Provide technical input into environmental/facility/process monitoring deviations to determine impact on batch disposition and CAPA.
• Collaborate to resolve manufacturing investigations related to aseptic control events.
• Design and implement risk-based approaches to control bioburden for drug substance and product.
• Support regulatory submissions and pre-approval inspections related to contamination control for aseptic operations.
• Coordinate with CDMOs and engineering firms to enable aseptic filling in GMP environments.
• Establish processes for post-approval control strategies and performance monitoring with external CMOs.

Skills

Aseptic processing

Sterility assurance

GMP

Root cause analysis

Process development

Biologics manufacturing

Cell therapy

Regulatory knowledge

Education

Biology or Engineering degree

PhD preferred

Job description

Vertex Pharmaceuticals LLC in Boston, MA seeks a Principal Scientist Aseptic Control with expertise in sterile and low bioburden processing technologies for cell & gene therapy and biologics. The role partners with stakeholders to define microbial control strategies and ensure cGMP compliance across sites, including CDMOs and engineering firms.

The incumbent will lead investigations, develop risk-based approaches for contamination control, and support regulatory submissions in a GMP