Director Biologics Manufacturing
At Avidity Biosciences, we are passionate about the impact of every employee in bringing potentially life-changing therapeutics to patients in need. Avidity is pioneering a new class of oligonucleotide-based therapies called AOCs, designed to overcome the current limitations of oligonucleotide therapies to treat a wide range of serious diseases. We utilize our proprietary AOC platform to design, engineer and develop transformative therapeutics that combine the tissue selectivity of monoclonal antibodies (mAbs) and the precision of oligonucleotide-based therapies to access previously undruggable tissue and cell types and more effectively target underlying genetic drivers of diseases. If you are a committed, solution-oriented thinker, come make a difference with us.
We are seeking a Director Biologics Manufacturing who is experienced, highly energetic, and interested in helping Avidity grow into a late-stage clinical and commercial manufacturing company. The Director Biologics Manufacturing will manage all aspects of Avidity’s GMP antibody production, including upstream and downstream process optimization, and scale-up to support Phase 3 and commercial manufacture. A strong knowledge of all stages of CHO cell mAb production is required as well as a working knowledge of cGMP and FDA/EMA guidelines. The Director Biologics Manufacturing will be responsible for authoring and reviewing module 3 IND/IMPD and future BLA/MAA sections related to mAb manufacture, characterization and testing.
Essential Duties and Responsibilities
- Assume technical responsibility for Avidity’s mAb CMOs and provide subject matter expert (SME) guidance for process optimization/improvement, scale up, troubleshooting and manufacturing.
- Work with CMOs and QA to ensure timely release of all mAb batches.
- Responsible for leading scale-up activities from current Phase 1 (single use bioreactor) process to future Phase 3 / commercial production scale.
- Work with QC, QA and Analytics to refine mAb specifications as programs advance through clinical development.
- Work with CMOs, QA and Supply Chain to ensure timely delivery of mAb to drug substance sites in time for DS manufacturing.
- Provide Person-In-Plant support during mAb manufacturing runs.
- Provide CMC support for regulatory filings including INDs, CTAs, amendments and NDA/BLA as needed. Coordinate vendor regulatory support and ensure communication between Avidity Regulatory Affairs and CMOs.
- Work with CMC team to design and manage development studies supporting clinical advancement and commercialization.
- Manage technical review of batch records, OOS, OOT, deviations, change controls, nonconformance investigations, etc.
- Ensure adherence to applicable regulations including FDA, EMA, ICH, GCP, GMP and Avidity policies and procedures.
- Minimum Bachelor’s degree in biology, cell/molecular biology, or related field required.
- Minimum of 10 years of pharmaceutical industry experience in manufacturing of monoclonal antibodies with 6 years in a leadership role.
- Demonstrated experience in the manufacture of humanized monoclonal antibodies using recombinant protein expression technology in CHO cells is required.
- Deep understanding of both upstream cell culture and downstream purification processes is required.
- Experience with both fed batch and continuous perfusion processes.
- Experience in GMP manufacturing required, along with strong understanding of US, EU and JP regulations.
- Experience working with third-party CMOs required.
- Knowledge of cGMP, ICH, FDA, EMA guidelines regarding mAb supply and characterization.
- Working knowledge of mAb productivity and scale improvements as clinical programs advance.
- Proven track record of effective internal and external collaboration.
- Excellent communication and interpersonal skills and the ability to facilitate constructive, expedient problem-solving.
- Ability to multi-task, manage conflict, and work in a fast-paced environment.
Avidity is committed to complying with federal, state and local law on employee vaccinations. Job candidates should be aware that full vaccination against COVID-19 may be required in the future. Avidity is an equal opportunity employer and encourages potential or current employees to request a reasonable accommodation under federal, state and local regulations, should one be needed.