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

genezenlabs; Lexington (MA); On-site; USD 170,000 - 190,000; Full time

Job summary

Genezen in Lexington, MA seeks an Associate Director of MSAT to lead strategic and operational efforts for manufacturing processes, ensuring GMP compliance and alignment with business goals. This role drives process excellence, scalability, and continuous improvement across new and existing programs with cross-functional collaboration.

The position requires leadership experience in pharma/biologics manufacturing, ability to mentor teams, and strong knowledge of quality systems and regulatory

Qualifications

• 7+ years operating in sterile GMP fill finish/Cell and Gene therapy.
• 3+ years in CDMO GMP fill finish/Cell and Gene therapy.
• Proven leadership and ability to influence cross-functional teams.
• Strong knowledge of quality systems, CAPA, deviations and regulatory filings.

Responsibilities

• Provide strategic leadership for MSAT to support new and commercial manufacturing.
• Lead process technology transfer from development to manufacturing for clinical and commercial programs.
• Mentor and lead a team of direct reports and cross-functional collaborators.
• Collaborate with PD, Manufacturing, QC, QA, Engineering, SC, Validation, CMC and Regulatory affairs to ensure readiness for manufacturing.

Skills

GMP leadership

Process transfer

Quality systems

Statistical analysis

Regulatory knowledge

Education

Bachelor's degree in Biotechnology/Biochemistry/Chemical Eng.

Master's or PhD in a scientific discipline

Job description

WORKING AT GENEZEN

The field of gene therapy is growing rapidly and Genezen is here to meet the exacting needs of our clients. We provide process development, produce GMP viral vectors, and provide cell transduction for gene and cell therapy clinical trials and are proud to be a part of the process that leads to new cures.

Many people have worked in environments where you feel like just another nameless part of an enormous machine. Genezen is different. We want our employees to be innovative, collaborative problem solvers who are dedicated to meeting the challenges of working at a fast-growing company. We are dedicated to empowering our employees to be their best and making Genezen a rewarding place to work. Every employee contributes to the success of the company and you can be part of that team.

JOB SUMMARY

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.

JOB 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 that cross functional teams are functioning smoothly to deliver and maintain processes and controls that are timely, phase-appropriately ready for manufacturing to meet clinical and commercial supply needs.
• Ability to 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.
• Identifies personnel needs, trains, develops, and motivates 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.

SPECIAL WORK REQUIREMENTS

• Adaptability required as work schedule may change based on business needs
• Criminal background check required
• Other duties as assigned

EDUCATION/CERTIFCATIONS/LICENSES

Bachelor's 1 0 + , Master's or PhD 7 + in a scientific discipline such as Biotechnology, Biochemistry, Chemical Engineering, or related field.

ON-THE-JOB EXPERIENCE

• 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

KNOWLEDGE, SKILLS AND EXPERIENCE

• Proven leadership and subject matter expertise for pharmaceutical biologic manufacturing, Upstream processing, Downstream processing, TFF, technology transfer and process validation. Essential
• Strong leadership in team management, decision making, change management, collaboration, delivering desired business results, and ability to influence. Essential
• 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) Essential
• Ability to generate, manage, evaluate, and maintain critical data in a highly organized manner. Essential
• Experience with statistical analysis or process data Essential
• Able to provide technical leadership in solving clinical and commercial drug manufacturing process issues involving equipment, parameter controls, and raw materials. Essential

COMPENSATION RANGE

The compensation range for this position is dependent upon experience level of the successful candidate. The ranges are as follows:

Sr. Manager- $150,000-$170,000

Assoc Director - $170,000-$190,000

Work Environment

Regularly sit for long periods of time

Ability to use personal protective equipment, if needed to be in a BSL2 environment

Movement

Repeated hand movements, typing, use of keyboard and mouse

Frequently required to stand; sit; use hands to finger, handle, or feel; reach with hands and arms

Occasionally required to walk; climb or balance; and stoop, kneel, crouch, or crawl

Lifting

Frequently lift and/or m