Research Associate 1 or 2 Research Associate 1/2, In Vivo Pharmacology
DIRECTOR/SENIOR DIRECTOR OF BIOLOGICS DEVELOPMENT

BRIS 2.117

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‚Äôs 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

REQUIREMENTS:

  • PhD in Biology, Biochemistry, Chemical Engineering or other related discipline
  • 10+ years of biopharmaceutical industry experience with no less than 7 years of that experience focusing on biologics process development and/or manufacturing (upstream & downstream)
  • Experience writing and supporting regulatory filings including IND and BLA and supporting product-related inspections for US and foreign regulatory agencies
  • Experience developing, implementing and executing internal and external strategic plans and objectives
  • Proven experience working with external manufacturing and analytical testing organizations
  • Demonstrated track record of leading CMC related activities from IND enabling into clinical development and through commercialization.
  • In-depth understanding of ICH guidelines and GMP requirements for development and manufacturing of biologics
  • Solid understanding of industry best practices and regulatory expectations associated with QbD, comparability evaluation, scale up, and method and process validation
  • Exceptional interaction, leadership and communication skills

Please send resume and cover letter