UNITY Biotechnology is seeking an exceptional and highly motivated individual to lead the 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.

Responsibilities

• 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