Associate Director Manufacturing Science and Technology (MSAT)
Location: San Diego, CA
Manufacturing Science and Technology (MSAT) is a partner of biologics manufacturing operations and is the custodian of manufacturing processes with strong collaboration from the Process Development group. Manufacturing Science ensures manufacturing processes are capable, compliant, in control, cost effective, and continuously improved. This position joins the Downstream MSAT to establish and provide direction, planning and execution of cGMP clinical phase manufacturing operations.
Typical Duties Include:
- Regularly evaluate Downstream MSAT operations, developing and implementing recommended and/or necessary improvements and changes.
- Provide management direction and oversight to the Downstream Manufacturing staff, serving as a role model while providing career development and direction.
- Responsible to evaluate all Downstream MSAT operations, including human resources. Develop and issue performance standards, objectives and goals. Evaluate staff performance and initiate appropriate action(s) when necessary.
- Propose, plan, organize and execute MSAT manufacturing in production-scale protein manufacturing.
- Recommend strategies for improving purification procedures for top performance through the use of bioprocess engineering principles and protein biochemistry.
- Provide a science-based approach for the resolution of deviations, investigations, and process issues through analysis of historical data and scale-down studies.
- Network with Process Development, Manufacturing, and Quality organizations to establish a reliable state of process control.
- Actively participate in technical transfer and implementation of purification processes including facility fit modeling based on client needs.
- Actively participate in process validation activities.
- Build, modify, and utilize digital data storage, visualization, and analysis systems such as Minitab and/or JMP and custom web-based interfaces to enable site process monitoring and continuous process verification programs.
- Generate documents (technical memos, protocols, reports) related to process monitoring, product impact assessments, campaign end summary reports.
- Provide training as needed and ensures adherence to company policies and quality requirements.
- Abzena is currently in the process of building a state-of-the-art biologics manufacturing facility heavily leveraging disposable technology. The candidate will have the opportunity to support multiple manufacturing commissioning projects.
- Operates to the highest ethical and moral standards.
- Complies with Abzena’s policies and procedures.
- Adheres to quality standards set by regulations and Abzena policies, procedures and mission.
- Communicates effectively with supervisors, colleagues and subordinates.
- Ability to participate effectively as a team player in all aspects of Abzena’s business.
- Travels as needed to attend professional conferences, and train on new technologies.
- Bachelor’s degree in Chemical Engineering, Biochemistry, or equivalent.
- 5-10 years of relevant purification MSAT experience.
- Skill leading MSAT manufacturing people, production and process development-related activities.
- Ability to ensure plans and resources (people, facilities, supplies, etc.) are efficiently utilized to ensure uninterrupted supply of products produced.
- Ability to work complex assignments of diverse scope and ability to exercise judgment within both novel and defined practices and procedures to determine appropriate actions.
- Expert knowledge of protein purification techniques involving chromatographic and filtration-based technologies.
- Skill in operations of AKTA explorer, AKTA-Ready, Flex-ACT, Starto-Flow and other disposable downstream skids.
- Expert knowledge in creation of process methods/recipes using GE unicorn software.
- Proficient knowledge with MS Office including Excel, PowerPoint, and Word.
- Experience within biologics CMC that includes pilot plant and/or cGMP manufacturing.
- Experience in technology transfer from development into a cGMP Manufacturing.
- Demonstrated success in technical proficiency, scientific creativity, and collaboration with others.
- Ability to clearly communicate scientific information both written and oral.
- Ability to present technical information to both technical and non-technical audiences is required.
- Ability to demonstrate sound judgment and problem-solving capabilities with exceptional interpersonal skills.
- Strong organizational skills are required.
- Project management experience is a plus.