Associate Director/Director, CMC

Manufacturing La Jolla, California


Description

Avidity Biosciences is pioneering a new class of oligonucleotide-based therapies called AOCs designed to overcome the current limitations of oligonucleotide therapies in order to treat a wide range of serious diseases. We utilize our proprietary AOC platform to design, engineer and develop therapeutics that combine the tissue selectivity of monoclonal antibodies (mAbs) and the precision of oligonucleotide-based therapies in order to access previously undruggable tissue and cell types and more effectively target underlying genetic drivers of diseases.

The Associate Director/Director, CMC, will be responsible for overseeing the GMP manufacturing of monoclonal antibodies and antibody oligonucleotide conjugates at CMOs. This position will lead technology transfer, process development and GMP manufacturing operations at CMOs to enable Avidity’s rapidly growing clinical programs. The Associate Director/Director, CMC, will serve as mAb, AOC drug substance and drug product subject matter expert and will author the CMC section of regulatory documents.

Primary Responsibilities:

  • Develop and implement strategy for the manufacture of AOCs from Ph1 through approval
  • Manage Avidity's drug substance and drug product manufacture at CMOs and ensure uninterrupted supply of multiple drug products for clinical trials
  • Manage Avidity’s antibody scale up and manufacture at CMOs
  • Manage manufacturing operations, including technology transfer, process development, scheduling, logistics, batch record review, change controls, review of validation protocols, and development of specifications
  • Serve as subject matter expert for antibody, drug substance and drug product manufacture
  • Coordinate across functional areas, including process research, project management, clinical development and operations, and finance, to ensure successful and on-time manufacturing of multiple products
  • Report CMC strategy, progress, and challenges to executive management
  • Oversee late-stage development activities, registration, and manufacturing process validation
  • Author CMC sections of regulatory documents, including IND amendments and BLAs
  • Work collaboratively with quality, regulatory, discovery and commercial groups to meet project goals

Qualifications, Required Experience & Skills:

  • PhD, MS, or BS in chemistry with relevant expertise in GMP manufacturing of mAbs and antibody conjugates
  • Knowledgeable in organic synthesis, bioconjugation chemistry, and protein sciences
  • Previous experience in GMP manufacturing of mAb and antibody conjugates is a must
  • Experience in launching and commercializing new products a plus
  • Deep knowledge of Good Manufacturing Practices (cGMP)
  • Ability to work in a dynamic and fast-paced, timeline-driven biotech environment
  • Understanding quality and regulatory requirements in the pharmaceutical industry pertaining to ICH, GMPs and USP guidance and standards is necessary
  • Demonstrated ability to create and implement both short-term and long-term plans to support Avidity’s CMC goals
  • Excellent knowledge and understanding of analytical methods and validation

Avidity offers very competitive benefits and is an Equal Opportunity Employer.