Director, Engineering Operations (Cell and Genetic Therapies)
Location
Boston, MA
Level
VP / Executive
Department
MedTech
Type
Salary
$187,000 - $281,000
Job Description
Posted on:
2026-01-29
Responsibilities
- Develop and implement a strategy for engineering support of internal GMP manufacturing facilities.
- Lead the Validation Team to ensure compliance with regulatory requirements for CGT manufacturing.
- Oversee the Process/Project Engineering Team to identify skill gaps and support manufacturing operations.
- Manage the Manufacturing Technical Operations Team to maintain quality management systems and facilitate investigations.
- Direct the Digital Systems Team for lifecycle management of digital systems related to cell manufacturing.
- Collaborate with key stakeholders to support the integrated operations launch plan for CGT programs.
- Drive operational excellence and continuous improvement across the supply chain.
Job Requirements
- 10-15 years of experience in GMP Manufacturing/Process Engineering leadership roles in the Biopharmaceutical industry.
- Bachelor’s degree in an Engineering discipline; advanced degree preferred.
- Expertise in Manufacturing Related Process Engineering and Project Engineering.
- Proficient in investigations, root cause analysis, and regulatory compliance for commercial drug product manufacturing.
- Experience in building and managing high-performing teams in complex biologics manufacturing operations.
- Strong communication and interpersonal skills.
- Ability to anticipate challenges and develop contingency plans.
