Senior MSAT Manager, Biologics Process Transfer

Lever, Inc.; San Diego (CA); On-site; USD 160,000 - 180,000; Full time

Job summary

Abzena is seeking a Manager of Manufacturing Sciences and Technology (MSAT) to lead technical transfers and support Biologics manufacturing for clinical and commercial programs. You will guide MSAT staff, ensure cGMP compliance, and partner with Process Development, Quality and Operations to optimize scale-up and transfer to manufacturing.

The role emphasizes leadership, problem solving, and a science-based approach to deviations and investigations, with a focus on delivering high-quality

Qualifications

• 5+ years of direct experience in Biologics Manufacturing, Process Development and/or MSAT.
• Expertise in Upstream or Downstream Biologics Manufacturing.
• 3+ years of people management experience with leadership and teamwork.
• Strong cGMP background and demonstrated delivery on cross-functional projects.
• Solid scientific background in biologics products for cGMP clinical operations.
• Proven ability to communicate project tech transfer targets to management and staff.

Responsibilities

• Oversees MSAT staff in tech transfer from PD to large-scale biologics manufacturing.
• Oversees MSAT staff supporting on-the-floor cGMP operations for tech-transferred programs.
• Guides implementation of new manufacturing equipment and automation for cGMP production.
• Establishes and maintains cGMP manufacturing processes.
• Collaborates with Quality to ensure regulatory standards are met.
• Provides technical and problem-solving support to Manufacturing Operations and Quality.
• Develops process knowledge into a manufacturing controls strategy for scale-up and transfer.
• Supports Manufacturing to resolve complex process/product issues.
• collaborates with Process Development on data trends for optimization opportunities.

Skills

Biologics manufacturing experience

Leadership

Communication

cGMP operations

Tech transfer

Problem solving

Team collaboration

Process development collaboration

Data trend analysis

Education

Bachelor's degree in Life Sciences or Engineering

Advanced degree (Master's or PhD)

Job description

Abzena is seeking a Manager of Manufacturing Sciences and Technology (MSAT) to lead technical transfers and support Biologics manufacturing for clinical and commercial programs. You will guide MSAT staff, ensure cGMP compliance, and partner with Process Development, Quality and Operations to optimize scale-up and transfer to manufacturing.

The role emphasizes leadership, problem solving, and a science-based approach to deviations and investigations, with a focus on delivering high-quality