Associate Director, Process Development and Manufacturing

The Opportunity

The Associate Director of AOC Process Development and Manufacturing – Bioconjugation is a senior leader accountable for managing all aspects of AOC drug substance (DS) process development and manufacturing including the scale-up to Phase 3 and commercial. A strong knowledge of bioconjugation chemistry, purification techniques and analytical methods is required as well as a working knowledge of cGMP and FDA/EMA guidelines.

The Associate Director AOC Process Development and Manufacturing will be responsible for authoring and reviewing module 3 IND sections as well as BLA sections related to AOC DS manufacture and will lead our tech transfer and scale-up activities for all of Avidity’s AOC DS manufacture.

What You Will Contribute

• 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.
• Career development and professional growth opportunities.

What We Seek

• 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.

Additional Details

• Title: Associate Director of AOC Process Development and Manufacturing, Bioconjugation
• Location: San Diego, CA/ Hybrid/ Remote
• Position Type: Full Time / Exempt
• Department: Process Development - Bioconjugation
• ID: 3104-2026-1/ 3104-2026-2
• #LI-Remote