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

The role

The Associate Director, MSAT provides strategic and operational leadership for manufacturing processes in Lexington, MA. This role drives process excellence, scalability, and continuous improvement for clinical and commercial products.

What you will do

• 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 cross functional teams to deliver and maintain processes and controls.
• 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.
• Identifies personnel needs, trains, develops, and motivates subordinates.
• Author/review relevant CMC sections of clinical and commercial product regulatory filings.
• Author technical reports, risk assessment documents, and prepare scientific presentations.

Required qualifications

• Bachelor’s 10+ years in a scientific discipline such as Biotechnology, Biochemistry, Chemical Engineering, or related field.
• Master’s or PhD 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.

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

Before you apply

• Criminal background check required
• Genezen is not able to sponsor visas.

About the company

Genezen provides process development, produces GMP viral vectors, and provides cell transduction for gene and cell therapy clinical trials.