Senior Director, Oligonucleotide Process Development

4 days ago


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

We are seeking an experienced Associate Director to lead our Oligonucleotide Process Development and Manufacturing team. As a key member of our Technical Development department, you will be responsible for managing all aspects of Oligonucleotide process development and manufacturing, including scale-up to Phase 3 and commercial. Your expertise in Oligonucleotide synthesis and purification, as well as your knowledge of cGMP and FDA/EMA guidelines, will be essential in ensuring the success of our clinical programs and commercial supply chain.

Key Responsibilities
  • Assume technical responsibility for Avidity's Oligonucleotide CMO process development and manufacturing for one or more programs.
  • Provide subject matter expert (SME) guidance for Oligonucleotide 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 Oligonucleotide intermediate.
  • Author relevant sections of Regulatory filings, including INDs, IND amendments, and BLAs.
Requirements

We are looking for a highly experienced professional with a strong background in Oligonucleotide process development and manufacturing. Your expertise should include:

  • Minimum of 8 years of pharmaceutical industry experience in Oligonucleotide synthesis and purification at large scale.
  • Expertise in Oligonucleotide process development, 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 and a strong understanding of US, EU, and JP regulations are required.
  • Prior IND and BLA filing experience.
What We Offer

We offer a competitive compensation package, including a base salary range of $167,000 - $194,000, as well as opportunities for annual and spot bonuses, stock options, and RSUs. Our comprehensive wellness program includes coverage for medical, dental, vision, and LTD, as well as four weeks of time off. We are committed to learning and development, with a variety of programming internally developed by and for Avidity employees, opportunities for job-specific training offered by industry, and an education reimbursement program.



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