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Associate Director/Director, CMC

Company: Avidity Biosciences
Location: San Diego
Posted on: September 15, 2020

Job 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

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Keywords: Avidity Biosciences, San Diego , Associate Director/Director, CMC, Other , San Diego, California

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