Director of Protein Manufacturing

Job Purpose

The job is primarily focused on management of a manufacturing team that purifies collagenase and protease enzymes used for the development of new cell-based therapeutics and pharmaceuticals. The candidate is expected to support an ISO-9001:2015 culture that uses Toyota’s manufacturing philosophy to guide its adherence to the Standard.

Education/experience

• An B.A./B.S., M.S., or Ph.D. in Chemistry, Biochemistry, Biology or related life science discipline
• ≥ 10 years direct experience working in a biological laboratory
• ≥ 5 years direct experience in manufacturing biological products under a document controlled, Quality Management System
• Experience managing/directing a biological manufacturing team

Skills, Knowledge Abilities

• Rigorously disciplined adherence to established procedures and protocols
• Experience in protein chromatography, characterization, filtration, and downstream processing
• Strong interpersonal skills with a desire and ability to work with others in a team environment to accomplish team and individual goals
• Detail orientated and meticulously attentive to ongoing processes with the ability to identify trends, problems, or opportunities for potential improvement
• Strong problem-solving skills with an ability to clearly articulate the rationale to solve the problem
• Proficiency in Microsoft Office products

Responsibilities

• Direct the Manufacturing Scientists in the purification and the compounding manufacturing processes of all products
• Manage the manufacturing schedule in coordination with the sales and marketing team to ensure ample supplies of all intermediate materials and final products while managing costs and maintaining appropriate inventories
• Ensure the integrity and quality of materials and products at all points during the manufacturing process
• Ensure all individuals in the manufacturing team are appropriately trained per the procedures in the Quality System and responsibilities are understood
• Diligently ensure all manufacturing batch records are completed accurately with periodic reviews and audits
• Manage the corrective the preventive activities of the manufacturing team
• Follow established procedures to properly maintain, calibrate, qualify and clean equipment and instruments used in the manufacturing process
• Work with other functional groups to Identify and implement process improvement activities that directly ensure maintained product quality, reducing costs and improving efficiency
• Initiate corrective and preventive action projects to constantly ensure the manufacturing process is operating in the best interest of the whole organization
• Cultivate new skills and leverage strengths of individuals on the manufacturing team to retain company talent

Pay

Salary is commensurate with experience.