Associate Director, AOC Process Development and Manufacturing

6 days ago


San Diego, California, United States Avidity NanoMedicines Full time
The Opportunity

We are seeking an experienced Associate Director to lead our AOC Process Development and Manufacturing team. As a senior leader, you will be responsible for managing all aspects of AOC drug substance process development and manufacturing, including scale-up to Phase 3 and commercial. Your expertise in bioconjugation chemistry, purification techniques, and analytical methods will be essential in ensuring the success of our AOC platform.

Key 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 and scale-up.
  • Develop and execute late-stage manufacturing strategy to meet Avidity's advancing pipeline.
  • Work with CMOs and QA to ensure timely release of AOC DS.
  • Author relevant sections of Regulatory filings, including INDs, IND amendments, and BLAs.
Requirements
  • Minimum Bachelor's degree in chemistry, chemical engineering, pharmaceutical science, or related field required.
  • 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.
What We Offer

Avidity offers a competitive compensation package, including a base salary range of $167,000 - $194,000, annual and spot bonuses, stock options, and RSUs, as well as a 401(k) with an employer match. We also offer a comprehensive wellness program, including medical, dental, vision, and LTD coverage, and four weeks of time off.



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