Associate Director, Process Development and Manufacturing

About the role

Avidity Biosciences, Inc. is revolutionizing the field of RNA therapeutics with its proprietary AOC platform. The Associate Director of AOC Process Development and Manufacturing – Bioconjugation will manage all aspects of AOC drug substance (DS) process development and manufacturing, from 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.
• Care for coordination 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.
• 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.

Qualifications

• 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.
• 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.

Skills

• Strong knowledge of bioconjugation chemistry, purification techniques and analytical methods.
• Working knowledge of cGMP and FDA/EMA guidelines.

Benefits

To be provided: Competitive compensation and benefits including annual and spot bonuses, stock options and RSUs, a 401(k) with an employer match, and a comprehensive wellness program covering medical, dental, vision, and LTD. Additional benefits include a commitment to learning and development, and an 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

Hybrid/Remote Position Type: Full Time / Exempt