UNITY Biotechnology is seeking an exceptional and highly motivated individual to lead the CMC Biologics Development group. Reporting to the Head of Operations, the individual will lead biologics development activities across a dynamic development and discovery space. The successful candidate will be flexible, have strong leadership skills, and have experience in developing robust manufacturing processes supporting biologics-based clinical programs.
- Advancing biologics candidates in UNITY’s pipeline by providing internal and external CMC guidance, oversight, and direction for biologics projects, including mAbs and proteins, from pre-IND to commercialization
- Establish strong relationships with UNITY Discovery, Quality Assurance, Clinical Operations, and Clinical Supply Chain Organizations
- Support regulatory filings by authoring, reviewing, and adjudicating all biologics CMC sections
- Hire, mentor and develop team members within the organization
- Translate non-clinical and clinical study demands of biologics candidates to development and manufacturing timelines.
- Actively manage, provide technical support, and oversee the outsourcing of cell bank generation, drug substance and drug product manufacturing.
- Initiate and support UNITY legal and procurement with non-disclosure agreements, master services agreements and statements of work
- Prepare, review and negotiate request for proposals (RFP) and participate in due diligence evaluations of potential biologics CMOs
- Organize and lead teleconferences and face-to-face meetings with CMOs
- Develop and execute DS and DP PPQ studies
- Develop and maintain internal and external project timelines to ensure biologics development programs progress towards established corporate goals
- Represent the Operations functions at multidisciplinary program team meetings