Sr. Manager/Assoc Director, Manufacturing Sciences & Technology (MSAT)

Genezen•Lexington, MA

5d•Onsite

About The Position

The Associate Director, Manufacturing Sciences & Technology (MSAT) provides strategic and operational leadership for Genezen’s Lexington, Massachusetts manufacturing processes. The role supports successful technology transfers and the manufacture of clinical and commercial products, ensuring alignment with business objectives and compliance with GMP guidelines. It drives process excellence, scalability, and continuous improvement across new products and existing programs while fostering cross-functional collaboration and organizational growth. The position may be filled at the Senior Manager or Associate Director level, with compensation depending on experience.

Requirements

Bachelor’s degree and 10 or more years of relevant experience, or a Master’s degree or PhD and 7 or more years of relevant experience, in a scientific discipline such as Biotechnology, Biochemistry, Chemical Engineering, or a related field.
At least 7 years of experience operating in a sterile GMP fill-finish or cell and gene therapy site.
At least 3 years of experience in the CDMO industry in GMP fill-finish or cell and gene therapy.
Leadership and subject matter expertise in pharmaceutical biologic manufacturing, upstream and downstream processing, TFF, technology transfer, and process validation.
Strong leadership skills in team management, decision-making, change management, collaboration, achieving business results, and influencing others.
Detailed knowledge of quality fundamentals, quality control, quality management systems, investigational tools, and deviation writing.
Detailed understanding of process characterization studies and risk assessment tools such as FMEA.
Ability to generate, manage, evaluate, and maintain critical data in an organized manner.
Experience with statistical analysis or process data.
Ability to provide technical leadership in resolving clinical and commercial drug manufacturing process issues involving equipment, parameter controls, and raw materials.
Adaptability to changing work schedules based on business needs.
Ability to complete a criminal background check.
Eligibility to work in the United States; the company is unable to sponsor visas.

Responsibilities

Provide strategic MSAT leadership in support of new and commercial manufacturing operations.
Lead process technology transfers from process development to clinical and commercial manufacturing.
Manage, mentor, and lead direct reports.
Collaborate with Process Development, Manufacturing, QC, QA, Engineering, Supply Chain, Validation, CMC, and Regulatory Affairs to maintain timely, phase-appropriate processes and controls for manufacturing.
Represent technical process topics in client meetings.
Lead process validation, including PPQ strategy and execution, data analysis, and campaign summary reports.
Oversee process monitoring and continued process verification (CPV) to support process robustness and identify capabilities and improvements.
Identify personnel needs, train and develop staff, and support manufacturing, technology transfers, process change controls, CAPAs, and deviation resolution.
Author or review relevant CMC sections of clinical and commercial regulatory filings and provide technical subject matter expertise during site regulatory inspections.
Author technical reports and risk assessment documents, and prepare scientific presentations as needed.