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

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
  

COMPENSATION RANGE

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 move up to 10 pounds
• Occasionally lift and/or move up to 25 pounds

Vision

• Frequently utilize close vision and the ability to adjust focus

Communication

• Frequently required to communicate by talking, hearing, using telephone and e-mail