Director of Protein Manufacturing

VitaCyte is an ISO-9001 certified company located in Indianapolis, Indiana. It is a leading manufacturer of purified-defined bacterial collagenase and associated protease enzymes for enzyme mediated cell isolation and other biotherapeutic applications

• 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
  • The appropriate candidate will have 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 nal 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 eciency
  • 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
• Full time, permanent position including a comprehensive family medical benefit package and participation in an employer matched 401K plan.
  • Salary is commensurate with experience.