Sr. Director/Director, CMC Operations

Posted 21 September 2022
Job type Permanent
Contact NameSam Heron

Job description

BioTalent is proud to be partnering with an exciting VC backed, Boston based biotech company focused on the treatment of Neurodegenerative diseases through their unique Protein based thereapeutics.


You would be responsible for building out and leading the CMC Operations function, both internally and externally.


Key responsibilities:


  • Lead the CMC development programs for the pre-clinical and clinical therapeutics
  • Lead Process Development of apolipoprotein based proteins for pre-clinical and clinical applications, allowing for Tech tansfer and scale-up at CDMO partners
  • Build out the CMC function in line with continued company growth
  • Work with Senior management to assess, develop and outline the technical and CMC strategy including:
  1. Assessment of potential collaborations with companies & academic instituations to enable technical strategy
  2. Identifying and engaging with tehcnical experts for opinion and expert advice
  3. Identification of technical risks within programs, then develop mitigation strategies
  • Oversee and manage the contracts, acitivies and relationships with CMO partners to ensure timely completions


You will have the following skills and qualifications:


  • PhD, MS or BS in Biology, Bioengineering, Chemical Engineering, Biochemistry or related field
  • At least 12 years biotech/pharma industry experience
  • Expert technical knowledge of protein biologics process development
  • Extensive knowledge in activities required for development of all aspects for process development and manufacturing (cell line, bioreactor, purification, formulation, fill/finish, analytics)
  • Direct experience managing technical development programs
  • Previous experience as a CMC lead strongly preferred, including CMC leadership of regulatory filings
  • Experience leading and supporting technical strategy development
  • Attention to detail and strong communication skills are required.
  • Passion for curing neurodegenerative diseases is a plus.