Director, MSAT

SUMMARY

The Director, Manufacturing Science and Technology (MSAT) is a key role in the leadership team, contributing to strategic business planning, and ensuring cross-functional collaboration. The Director MSAT will lead and enable a global MSAT organization as a strategic champion, 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. The Director MSAT is responsible for all functions in support of cGMP drug substance manufacturing, including technology transfer, process monitoring, troubleshooting, process validation, optimization of drug substance production processes and technologies, and client interactions. This individual will be self-motivated, detail-oriented, productive in team settings, a strong oral and written communicator across functional areas and technical levels, supportive manager and effective client liaison.

JOB RESPONSIBILITIES

Essential

? Apply highly advanced engineering principles to the transfer, monitoring, validation, and troubleshooting activities of drug substance manufacturing processes.

? Partner with cross functional teams at decision level including Process Development, Quality,

Supply Chain Management, External Manufacturing (Drug Product), Engineering and all clients.

? Drive implementation of new technologies to improve manufacturing efficiency and ease of operations.

? Plan and implement long range technology programs. Propose, design, and implement advanced major scientific experiments which contribute to the overall program objectives and extend the boundary of knowledge in their field.

? Oversight of all and participate in (as necessary) MSAT client interactions.

Leadership

• Create an environment of strong team spirit, timely and effective communications, sense of urgency, high motivation and inspire teams to achieve immediate and long-term goals.
• Be an active and visible change agent, promoting flexible and open mindsets to new opportunities.
• Drive collaboration within site and across network activities, cross-functional planning, and decision making.
• Proactively promote positive Safety Culture and cGMP operating principles.

? Manage and develop the MSAT team through:

• individual goal setting/performance reviews.
• provide coaching and feedback for individual career growth and development.
• recognize and appreciate employee contributions.
• mitigate conflict and communication problems.
• plan and facilitate team activities.
• recruit/hire personnel.
• provide training and emphasize best practices.

Supplemental Responsibilities

? 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.

JOB REQUIREMENTS

Education

? 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.

Knowledge, skills, and abilities

? 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.

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

? 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