The Manager of Manufacturing Sciences and Technology (MSAT) is a technical leadership position that directly supports product supply, strategic objectives, and client programs for Biologics manufacturing. Under the leadership of the MSAT Manager, the MSAT team is responsible for technical and process support of clinical cGMP Manufacturing using multiple production platforms. The scope of support includes ensuring smooth and efficient technical transfers into manufacturing, documentation and technical writing, advanced troubleshooting of complex problems, and continuous improvement. This position is also responsible for maintaining a safe work environment in compliance with CAL OSHA and other local, state, and federal regulatory agencies.
Shift B: 10 hour shifts, Wednesday through Saturday
Responsibilities
- Oversees and supports MSAT staff in executing tech transfer from PD to large-scale biologics manufacturing. In some cases, will directly support in this capacity, as needed.
- 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.
- Provides a science-based and risk-based approach for the resolution of deviations, investigations and process issues through analysis of in-process, historical and scale-down data.
- 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
FLSA: Exempt
Abzena is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws.
This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, and training.