Senior Aseptic Control Scientist, MSAT (Hybrid)

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

Benefits offered by this job

Hybrid-Eligible

On-Site Eligible

Job summary

Vertex Pharmaceuticals LLC seeks a Principal Scientist, Aseptic Control, to lead sterile and low bioburden processing strategies across cell and gene therapy programs. You will drive environmental monitoring, disinfection efficacy, aseptic simulations, and risk assessments to ensure cGMP compliance, while interfacing with internal and external sites.

Hybrid work in Boston. The role requires 10+ years in aseptic processing, strong regulatory acumen, and a track record of leading investigations

Qualifications

• At least 10+ years in aseptic drug product technical roles in process development or manufacturing.
• Experience implementing sterility assurance and containment strategies in GMP environments.
• Strong written and verbal communication, and ability to lead cross-functional teams.

Responsibilities

• Provide technical input on environmental/facility monitoring deviations and contamination events.
• Collaborate to design risk-based control strategies for bioburden and contamination prevention.
• Support regulatory submissions and inspections related to aseptic operations.
• Work with CDMOs and engineering firms to enable aseptic filling in GMP settings.
• Establish post-approval control strategy performance monitoring and OOC resolution.

Skills

Aseptic processing

Risk-based strategies

Gowning & clean rooms

Regulatory knowledge

Cross-functional collaboration

Education

Biological or engineering degree (microbiology preferred)

Tools

Environmental monitoring

Filtration/sterility testing

Job description

Vertex Pharmaceuticals LLC seeks a Principal Scientist, Aseptic Control, to lead sterile and low bioburden processing strategies across cell and gene therapy programs. You will drive environmental monitoring, disinfection efficacy, aseptic simulations, and risk assessments to ensure cGMP compliance, while interfacing with internal and external sites.

Hybrid work in Boston. The role requires 10+ years in aseptic processing, strong regulatory acumen, and a track record of leading investigations