Senior MSAT Leader: Process Transfer & Scale-Up

Genezen; Lexington (MA); Presencial; USD 150.000 - 190.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Paid vacation days

401(k) plan with company match

Healthcare plans

FSA and HSA programs

Life insurance

Disability insurance

Descripción de la vacante

Genezen in Lexington, MA is seeking an experienced Sr. Manager/Assoc Director, MSAT to lead the manufacturing sciences and technology organization for clinical and commercial programs.

The role focuses on strategic leadership, process excellence, scale-up, and cross-functional collaboration to ensure GMP-compliant, robust processes. The position requires deep knowledge of sterile GMP operations, technology transfer, process validation, and CDMO experience, with a track record of delivering

Formación

• 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/downstream processing, technology transfer and process validation.

Responsabilidades

• 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 deliver and maintain processes and controls that are timely and ready for manufacturing.

Conocimientos

Leadership

MSAT

Process validation

Cross-functional collaboration

Regulatory affairs

Educación

Bachelor's degree in a scientific discipline

Master's or PhD in a scientific discipline

Descripción del empleo

Genezen in Lexington, MA is seeking an experienced Sr. Manager/Assoc Director, MSAT to lead the manufacturing sciences and technology organization for clinical and commercial programs.

The role focuses on strategic leadership, process excellence, scale-up, and cross-functional collaboration to ensure GMP-compliant, robust processes. The position requires deep knowledge of sterile GMP operations, technology transfer, process validation, and CDMO experience, with a track record of delivering