Associate Director, Process Development and Manufacturing

About the role

Avidity Biosciences, Inc., a division of Novartis, is seeking an Associate Director of AOC Process Development and Manufacturing – Bioconjugation. This role is responsible for managing all aspects of AOC drug substance (DS) process development and manufacturing, including scale-up to Phase 3 and commercial stages.

Responsibilities

• Assume technical responsibility for Avidity’s AOC DS CMO process development and manufacturing for one or more programs.
• Provide subject matter expert (SME) guidance for AOC DS process development, tech transfer activities between CMOs and/or within CMOs for scale-up.
• Review batch records and provide SME guidance for deviations, investigations, change controls and preparation for manufacturing campaigns.
• Work with CMOs and QA to ensure timely release of AOC DS.
• Work with QC, QA and Analytics & Formulations to refine AOC DS specifications for late-stage clinical trials and commercialization.
• Work with CMOs, QA and Supply Chain to ensure timely delivery of AOC DS to DP manufacturing sites.
• Provide Person-In-Plant support for AOC DS manufacturing runs.
• Author relevant sections of Regulatory filings including INDs, IND amendments and BLAs.
• Cook with CMOs, QA and Supply Chain to ensure timely delivery of AOC DS to DP manufacturing sites.
• Coordinate AOC DS vendor regulatory support as needed and ensure communication between Avidity RA and AOC DS CMOs.
• Work with the QC stability team to ensure that AOC DS shelf-life extensions are executed in a timely manner. Provide SME oversight of AOC DS stability programs.
• Work with Analytics & Formulations team to design and manage AOC DS development studies supporting commercial launch.
• Develop and execute late-stage manufacturing strategy to meet Avidity’s advancing pipeline.
• Identify and communicate risks to clinical programs and commercial supply chain due to manufacturing delays.
• Participate in developing appropriate risk mitigation strategies for AOC DS supply.
• Ensure adherence to applicable regulations including FDA, EMA, ICH, GCP, GMP and Avidity policies and procedures.

Requirements

• Minimum Bachelor's degree in chemistry, chemical engineering, pharmaceutical science, or related field. Master's or PhD preferred.
• Minimum of 8 years of pharmaceutical industry experience in antibody/protein bioconjugation, ideally with oligonucleotides.
• Expertise in bioconjugation process development and manufacture, scale-up and technology transfer.
• Prior experience in clinical Phase 3/commercial readiness process development and manufacturing, Process Characterization and PPQ with knowledge of QA and Regulatory requirements for late-stage clinical and commercial manufacturing.
• Experience in GMP manufacturing required, along with strong understanding of US, EU and JP regulations.
• Experience working with third-party CDMOs.
• Prior IND and BLA/NDA filing experience.
• Experience working with third-party CMOs.
• Knowledge of cGMP, ICH, FDA, EMA guidelines regarding ADCs, or similar platforms.

Qualifications

• 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.

Benefits

• Competitive compensation and benefits including annual and spot bonuses, stock options and RSUs, and a 401(k) with an employer match.
• Comprehensive wellness program covering medical, dental, vision, and LTD.
• Four weeks of time off.
• Commitment to learning and development with various internally developed programming and opportunities for job-specific training.
• Education reimbursement program.

Pay

The base salary range for this role is $119,700 to $222,300. The final compensation will be commensurate with relevant experience, skillset, internal equity and market factors.

Schedule

This position is full-time and exempt. It is currently a hybrid/remote position based in San Diego, CA.