MSAT Director: Manufacturing Sciences & Technology

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

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