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

Genezen•Lexington, MA

5d•$150,000 - $190,000•Onsite

About The Position

Genezen’s MSAT group supports successful technology transfers and the manufacturing of clinical and commercial products. The Associate Director, MSAT provides strategic and operational leadership for manufacturing processes at Genezen’s Lexington, Massachusetts site, aligning work with business objectives and GMP requirements. The role drives process excellence, scalability, and continuous improvement across new products and existing clinical and commercial programs while fostering cross-functional collaboration and organizational growth. The position leads technology transfers from process development into clinical and commercial manufacturing, process validation and continued process verification, and technical support for manufacturing operations. It also manages and develops direct reports, collaborates with internal functions and clients, and contributes technical content to regulatory filings, reports, risk assessments, and presentations.

Requirements

Bachelor’s degree and 10+ years of experience, or a master’s degree or PhD and 7+ years of experience, in a scientific discipline such as biotechnology, biochemistry, chemical engineering, or a related field.
7+ years of experience working at a sterile GMP fill-finish or cell and gene therapy site.
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 capabilities in team management, decision-making, change management, collaboration, achieving business results, and influencing others.
Detailed knowledge of quality fundamentals, quality control, and quality management systems, including investigation 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 changes in work schedule based on business needs.
Ability to complete a criminal background check.

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 a team of direct reports.
Collaborate with Process Development, Manufacturing, QC, QA, Engineering, Supply Chain, Validation, CMC, and Regulatory Affairs to ensure processes and controls are ready for manufacturing and support clinical and commercial supply needs.
Represent technical process topics in client meetings.
Lead process validation, including PPQ strategy, execution, data analysis, and campaign summary reports.
Oversee process monitoring and continued process verification (CPV) to assess process robustness and identify capabilities and improvements.
Identify personnel needs; train, develop, and motivate team members supporting 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.