Senior Process Engineering Leader - GMP & Tech Transfer

Vertex Pharmaceuticals Incorporated; Boston (MA); On-site; USD 140,000 - 210,000; Full time

Benefits offered by this job

Annual bonus

Equity awards

Paid time off

Commuting subsidy

401(k)

Job summary

Vertex Pharmaceuticals Incorporated is seeking a Senior Manager, Process Engineering to lead manufacturing activities, drive technology transfer programs, and ensure compliant, scalable processes across late and early-stage development. You will work with CPI/DSDP teams at the Leiden Center and collaborate across cross-functional groups to align with quality requirements.

The role emphasizes strategic direction, stakeholder management, and people leadership, with a focus on delivering

Qualifications

• Advanced knowledge of GMP and CMC regulatory considerations.
• Experience managing projects in the pharmaceutical industry.
• Strong understanding of technology transfer and validation processes.
• Excellent communication and collaboration skills at all levels.
• Ability to manage multiple high-priority projects in a matrix environment.
• Mastery of data analysis and modeling.
• Knowledge of QbD and DOE principles.

Responsibilities

• Lead process engineering across manufacturing activities.
• Develop and implement tools, standards, and best practices.
• Represent Engineering on cross-functional CMC teams.
• Develop strategies for technology transfers and process validations.
• Establish relationships with suppliers and resources.
• Evaluate process performance using SPC and drive improvements.
• Resolve complex manufacturing issues with scientifically sound solutions.
• Support Leiden Center compliance needs and documentation.
• Lead and develop assigned staff with financial accountability.

Skills

GMP knowledge

Tech transfer

Data analysis

Cross-functional

QbD principles

DOE methods

Regulatory awareness

Education

PhD + 2+ yrs

MS + 5+ yrs

BS + 8+ yrs

Tools

Statistical software

Quality systems

Job description

Vertex Pharmaceuticals Incorporated is seeking a Senior Manager, Process Engineering to lead manufacturing activities, drive technology transfer programs, and ensure compliant, scalable processes across late and early-stage development. You will work with CPI/DSDP teams at the Leiden Center and collaborate across cross-functional groups to align with quality requirements.

The role emphasizes strategic direction, stakeholder management, and people leadership, with a focus on delivering