MSAT Manager - Shift B

Responsibilities

• Oversees and supports MSAT staff in executing tech transfer from PD to large-scale biologics manufacturing.
• Oversees MSAT staff supporting on-the-floor cGMP operations for cGMP production for tech-transferred programs.
• Oversees and provides guidance on the implementation of new manufacturing equipment and automation solutions for cGMP production in collaboration with Process Development and Equipment Engineering.
• Establishes, characterizes, and maintains cGMP manufacturing processes.
• Collaborates with Quality ensuring delivery of products meets regulatory standards.
• Provides ongoing technical and problem-solving support to Manufacturing Operations and Quality.
• Develops and translates process knowledge and understanding into manufacturing controls strategy (product, process, materials, environment, etc.) to ensure successful scale up and transfer.
• Supports Manufacturing to resolve complex process/product issues.
• Collaborates with Process Development in the gathering and analysis of manufacturing campaign data trends for process optimization opportunities for future client work.

Qualifications

• Bachelor's degree in a Life Sciences, Engineering or related discipline
• Advanced degree (e.g., Master’s or PhD preferred)
• 5+ years of direct experience in Biologics Manufacturing, Process Development and/or MSAT
• Expertise in either Upstream or Downstream Biologics Manufacturing is required
• 3+ years of people manager (e.g., lead, supervisor or higher) experience with ability to achieve results through teamwork and leadership of others, streamlined execution, and innovation
• Leadership and communication skills
• Proven track record in cGMP at scale manufacturing operations support, including problem solving and successful delivery of cross-functional technical projects
• Strong scientific background and expertise in biologics products for cGMP clinical operations
• Demonstrated ability to develop constructive and effective relationships with direct reports, colleagues, and senior management
• Demonstrated ability to effectively communicate project tech transfer targets to meet management, customers, and staff expectations

Pay

$160,000 - $180,000 a year

Schedule

Shift B: 10 hour shifts, Wednesday through Saturday