Head of Manufacture - Biotech
Head of Manufacture
(Title commensurate with level of experience)
The individual will be responsible and oversee all aspects of biologics manufacturing, process development and CMC from IND filing and first-in-human thru pivotal studies, and potentially commercial supply.
- Manage and lead development projects with external contract manufacturing organizations (CMOs), including cell line development, process development and manufacturing, quality assurance, and regulatory compliance. Negotiates contracts for product supply in coordination with legal and other personnel as required.
- Development and management of clinical, and potentially commercial, supply chains
- Responsible for outgoing quality, safety and efficacy of all finished products, including compliance with applicable specifications, SOPs, national regulations, and cGMP.
- Accountable and responsible for adequate deployment, implementation and utilization of quality systems, including compliance to cGMP and GDP. Implements and maintains appropriate SOPs and training. Identifies areas of supply risk.
- Lead CMC-relevant portions of regulatory filings and interactions
- Technology transfer
- Develops and implements long-term manufacturing and supply chain strategy and infrastructure appropriate to company evolution within corporate budgets and timelines – i.e., outsourcing vs. insourcing. If the latter, will be responsible for implementation and management of an insourced pilot manufacturing infrastructure.
- Responsible for talent management, as appropriate.
- Defines and executes budgets and timelines consistent with organizationally aligned objectives
- Provides strategic input and accurately projects development needs and requirements to support IND enabling studies and clinical development.
Desired Skills and Experience
- BS/MS or equivalent in science and/or engineering, or a biotechnology-relevant field (PhD preferred), with 15+ years of biotechnology experience including manufacturing activities of commercial products and supply chain management.
- Successful experience in the management of third-party CMOs Demonstrated experience in the knowledge of upstream and downstream unit operations (e.g. cell culture, fermentation, chromatography, filtration), formulation, analytics, manufacturing to scale, process development and technology transfer
- Successful track record in manufacture of biologics in various therapeutic areas including acute and chronic inflammation and oncology
- Previous success with regulatory submissions, including NDA/BLA or PMA, in a relevant therapeutic area. Understanding of ICH guidelines and regulatory requirements, including cGMP requirements and application.
- Prior experience with a start-up environment, and/or establishment of a pilot manufacturing plant(s), strongly preferred
- Outstanding analytical, problem-solving, organizational, communication and negotiation skills
- Able to travel domestically and internationally as needed
- Excellent skills in spoken and written communication including utilization of MS Office applications