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

The MSAT group plays a critical role in the successful tech transfers and manufacturing of clinical and commercial products. The Associate Director, MSAT provides strategic and operational leadership for Genezen's Lexington, MA manufacturing processes, ensuring alignment with business objectives and compliance with GMP guidelines. This role is responsible for driving process excellence, scalability, and continuous improvement across new products and existing clinical and commercial programs while fostering cross-functional collaboration and organizational growth.

Responsibilities

Provide strategic leadership for MSAT to support new and commercial manufacturing operations; Lead all aspects of process technology transfer from process development for clinical and commercial manufacturing; Manage, mentor and provide leadership to team of direct reports; Collaborate with Process Development, Manufacturing, QC, QA, Engineering, SC, Validation, CMC and Regulatory affairs and ensure cross functional teams are functioning smoothly to deliver and maintain processes and controls ready for manufacturing to meet clinical and commercial supply needs; Represent technical process related topics in client meetings; Lead all aspects of process validation including PPQ strategy, execution, data analysis and campaign summary reports; Responsible for process monitoring and CPV to ensure process robustness and to identify process capabilities/improvements; Identify personnel needs, train, develop, and motivate subordinates in support of manufacturing, tech transfers, process change controls, CAPAs, and deviation resolution; Author/review relevant CMC sections of clinical and commercial product regulatory filings and provide technical SME support during site regulatory inspections; Author technical reports, risk assessment documents, and prepare scientific presentations as needed; Other duties as assigned

Requirements

Bachelor's degree with 10+ years of experience, or Master's or PhD with 7+ years, in a scientific discipline such as Biotechnology, Biochemistry, Chemical Engineering, or related field; 7+ years of operating in a sterile GMP fill finish/Cell and Gene therapy site; 3+ years of experience in CDMO industry GMP fill finish/Cell and Gene therapy; Proven leadership and subject matter expertise for pharmaceutical biologic manufacturing, Upstream processing, Downstream processing, TFF, technology transfer and process validation; Strong leadership in team management, decision making, change management, collaboration, delivering desired business results, and ability to influence; Detailed knowledge of quality fundamentals, quality control, and quality management systems, including investigational tools and deviation writing; Detailed understanding of process characterization studies and risk assessment tools (FMEA); Ability to generate, manage, evaluate, and maintain critical data in a highly organized manner; Experience with statistical analysis or process data; Able to provide technical leadership in solving clinical and commercial drug manufacturing process issues involving equipment, parameter controls, and raw materials; Adaptability required as work schedule may change based on business needs; Criminal background check required

Benefits

Paid vacation days, amount based on tenure; Paid sick time; 10 observed holidays + 2 floating holiday + 1 volunteer day; 401(k) plan with company match up to 6% of salary; Share Appreciation Rights; Choice of several healthcare plans; FSA and HSA programs; Dental & vision care; Employer-paid basic term life/personal accident insurance; Voluntary disability, universal life/personal accident insurance; Accidental Death & Dismemberment (AD&D) Insurance