We are seeking an experienced and motivated Director, Technical Operations & Manufacturing to lead the contract manufacturing efforts in support of the advancement of personalized vaccines for the prevention and treatment of diseases with significant impacts on human health. Applicants should have a M.S. with 15 years industry experience in biologics or peptide development and/or manufacturing operations with preferably experience working with contract manufacturers. Experience in vaccine manufacturing is preferred. This position requires excellent leadership, organizational, communication, negotiating and interpersonal skills.
- Act as principal lead for interactions with Contract Manufacturing Organizations (CMOs)
- Identify and engage CMOs with support from Business Development and technical team leads
- Facilitate due diligence for selection of CMOs including quality audits
- Lead the development of RFPs and support contract negotiations, direct the set up and maintenance of CMO contracts, MSAs etc to support timely product supply
- Ensure CMOs meet required short term production schedules and resolve supply issues
- Provide oversight of process validation planning, coordination and execution
- Work with QA to facilitate resolution of CMO quality issues (e.g. non-conformances, investigations, CAPAs) and ensure regulatory inspection preparedness
- Provide managerial support for CMC Project Manager. Offer guidance, mentoring and professional development support and manage performance.
- Provide oversight of shipping logistics for manufactured materials
- Collaborate efficiently and effectively with the Chemical Development, and Analytical & Formulation Development groups to advance CMC activities
- Contribute to manufacturing strategy development, capacity planning and commercial planning
- Partner with project team members to align manufacturing plans with overall project plans
- Support regulatory document development and discussions with regulatory agencies.
- Monitor the industry for changes in CMO capabilities and capacity and identify opportunities.
- Excellent organizational, management, communication and interpersonal skills.
- Exceptional presentation and writing skills.
- A strong work ethic and sense of purpose
- A demonstrated ability to identify, analyze and solve problems.
- A good balance between being detail-oriented and setting direction/approach
- A team orientated management approach
Education and Experience Required:
- S. in Life Sciences or Engineering; MBA is a plus
- 15 years industry experience in biologics bulk manufacturing operations including late stage production
- 5 years experience managing contract manufacturing activities
- Demonstrated track record of success in delivering on clinical supply
- Strong knowledge of global cGMPs
- Vaccines manufacturing
- New product launch experience with CMOs
- Transfer of late stage processes to new manufacturing facilities