Associate Director, MSAT, Downstream

Bora Biologics•San Diego, CA

About The Position

It is the primary responsibility of the Associate Director, Manufacturing Science and Technology (MSAT), Downstream to lead and enable MSAT as a strategic champion, manager and Subject Matter Expert (SME) for mammalian and microbial drug substance manufacturing of biologics for clinical and commercial use in our contract development and manufacturing (CDMO) and in-house programs. MSAT scope includes process validation, technology transfer, process monitoring, continuous improvement and process support. The Associate Director is responsible for the MSAT team and all functions in support of cGMP drug substance manufacturing, including technology transfer, monitoring, troubleshooting, process validation, improving drug substance production processes and technologies and client interactions. The Associate Director serves as the Subject Matter Expert (SME) for the company’s current and emerging product portfolio. This role is pivotal in leading and advancing MSAT functions, supporting cGMP manufacturing.

Requirements

Bachelor’s or advanced degree in chemical/biochemical engineering, chemistry/biochemistry, biological sciences, or related disciplines.
BS with 15 years of relevant experience, or MS with 10 years of relevant experience, or PhD with 5 years of relevant experience in biopharmaceutical research and manufacturing settings.
5 years of management experience required.
Advanced experience with biopharmaceutical manufacturing process and equipment.
Proven track record of leading MSAT functions and implementing MSAT strategies.
Extensive knowledge of cGMP regulations/guidance and quality systems.
Must have an advanced understanding of statistical methods and their application in technology transfer and product lifecycle.
Ability to inspire and foster innovation, collaboration, transparency and team effectiveness.
Proficiency with MS Word, Excel, and PowerPoint.
Excellent interpersonal, verbal and written communication skills as well as digital literacy
Ability to function efficiently and independently in a changing environment
Proactive and willing to accept temporary responsibilities outside of initial job description

Nice To Haves

Familiarity with statistical software, such as JMP, is desirable.

Responsibilities

Utilize advanced engineering principles to facilitate the transfer, monitoring, validation, and troubleshooting of downstream manufacturing processes.
Collaborate with cross-functional teams, including Process Development, Quality, Supply Chain Management, Manufacturing, and Engineering, at decision-making levels.
Drive the adoption and implementation of new technologies aimed at improving manufacturing efficiency and streamlining operations.
Plan and execute long-term technology initiatives, including proposing, designing, and implementing advanced scientific experiments that contribute to program objectives and expand knowledge within the field.
Develop and support the MSAT team by motivating employees, providing coaching and feedback for individual career development, recognizing contributions, resolving conflicts, facilitating team activities, providing training, and promoting best practices.
Downstream Process Optimization: Lead optimization efforts for cell culture, fermentation, and other downstream process parameters to maximize yield and product quality.
Raw Material Management: Oversee qualification, sourcing, and supply of raw materials critical to downstream manufacturing processes.
Facility Fit: Assess the feasibility of new manufacturing processes, materials, and technologies and document as a facility fit reports.
Tech Transfer Documentation: Prepare comprehensive documentation to support technology transfer between sending sites or scales, ensuring knowledge continuity and regulatory compliance.
Client Interactions: Lead and facilitate client meetings and technical discussions to define downstream process design parameters, address process excursions, and resolve technical challenges collaboratively.
Continuous Improvement: Apply Lean, Six Sigma, or other continuous improvement methodologies to downstream operations, driving process efficiency and robustness.
Support the design and implement scale-down models with PD team to support troubleshooting, process characterization, and technology transfer activities.
Lead the collection and statistical analysis of manufacturing in-process control and process parameter data to monitor process performance and prepare campaign summary reports as required.
Guide investigations into process-related deviations, evaluate their impact on product quality, identify root causes, and recommend corrective and preventative actions.
Introduce and implement new equipment and process technologies in manufacturing areas, train personnel on these technologies, and act as a technical resource for equipment capabilities and troubleshooting.
Recommend and initiate improvements in process and equipment operation based on solid engineering and scientific principles to enhance process robustness, efficiency, and productivity.
Author standard operating procedures (SOPs) and batch records for new processes and technologies as needed.
Contribute to regulatory filings and inspections.
Collaborate with internal and external development and manufacturing teams to support process scale-up, technology transfer, process characterization, and validation.
Provide technical and process support on the manufacturing floor.
Deliver training and guidance on process and technical operations to manufacturing staff, and, if necessary, recommend and present disciplinary actions to subordinates.
Evaluate and/or test the feasibility and facility fit of new manufacturing processes, materials, and technologies
Lead collection and statistical analysis of manufacturing in-process control and process parameter data to trend process performance, generate campaign summary report as needed.
Lead manufacturing and process-related deviation investigations, assess impact to product quality, identify root cause and propose corrective and preventative actions.
Implement new equipment and process technologies in the manufacturing area and train manufacturing personnel on these technologies; serve as a technical resource on equipment capabilities and troubleshooting.
Initiate and recommend improvements in process and equipment operation, based on sound engineering and scientific knowledge, toward increasing process robustness, efficiency, and productivity.
Author SOPs and batch records for new processes and new technology as needed.
Contribute to and support all regulatory filings and inspections.
Collaborate in cross functional activities with development and manufacturing personnel, both internal and external, to support process scale-up, technology transfer, process characterization, process validation and process monitoring.
Provide process and technical support on the manufacturing floor.
Provide training and guidance on process and technical operations to manufacturing personnel recommend and present disciplinary actions to subordinates when required.