Senior Manager, Process Engineering

Vertex Pharmaceuticals LLC; Boston (MA); On-site; USD 150,000 - 190,000; Full time

Job summary

Vertex is seeking a Senior Manager, Process Engineering to provide technical, strategic, and operational leadership for complex manufacturing activities at Vertex's Leiden Center.

Responsibilities include developing manufacturing strategies for technology transfer and validation, influencing early and late-stage process development, managing cross-functional collaborations, and supporting GMP compliance.

Qualifications

• GMPs knowledge and CMC regulatory considerations.
• Proven project management in pharma.
• Experience with technology transfer and process validation.

Responsibilities

• Develop manufacturing strategies for technology transfer and validation.
• Influence early and late-stage process development.
• Manage cross-functional collaborations and support GMP compliance.

Skills

Technology transfer

Validation

Data analysis

QbD principles

Education

Bachelor's degree with 8+ years experience

Job description

Role: Senior Manager, Process Engineering

Provides technical, strategic, and operational leadership for complex manufacturing activities at Vertex's Leiden Center.

Responsibilities

Responsibilities include developing manufacturing strategies for technology transfer and validation, influencing early and late-stage process development, managing cross-functional collaborations, and supporting GMP compliance.

Requirements

• Bachelor's degree in relevant field (PhD with 2+ years, Master's with 5+ years, or Bachelor's with 8+ years experience), extensive knowledge of GMPs, CMC regulatory considerations, and proven project management in pharma.

Skills

• Skills in technology transfer, validation, data analysis, and QbD principles are essential.

Preferred

• experience managing manufacturing projects within biotech or pharma, strong stakeholder engagement, and leadership in a matrix environment.

High Value

• focus on process engineering within biopharma manufacturing, GMP, CMC regulatory compliance, technology transfer, validation, and working at the Leiden site.

Collaboration

• Collaboration with cross-functional teams including CPI and DSDP.

Work Setup

On-site five days/week with ad hoc flexibility.