Senior Director, AOC Process Development and Manufacturing - Remote

Overview

The Senior Director of AOC Process Development and Manufacturing is a senior leader managing a team accountable for all aspects of Oligonucleotide Process Development and Manufacturing, including initial tech transfer of Phase 1/2 and scale-up to Phase 3/Commercial Manufacturing.

In Short

• Lead the Oligonucleotide CMO process development and manufacturing team.
• Assume technical responsibility for Avidity’s Oligonucleotide CMO process development and manufacturing for one or more programs.
• Assume CMC Leadership on a program team for one or more programs (early and late phase).
• Provide subject matter expert (SME) guidance for Oligonucleotide process development and scale-up at our CMOs.
• Responsible for developing and executing late-stage process characterization, validation and manufacturing strategies in collaboration with our CMOs.
• Manage Oligonucleotide tech transfer activities between CMOs and/or within CMOs for scale-up.
• Work with QC, QA, and Analytics & Formulations to refine Oligonucleotide specifications for late-stage clinical trials and commercialization.
• Coordinate Oligonucleotide vendor regulatory support as needed and ensure communication between Avidity RA and Oligonucleotide CMOs.
• Author and review relevant sections of Regulatory filings, including INDs, IND amendments, and BLAs.
• Work with the QC stability team to ensure that Oligonucleotide shelf-life extensions are executed in a timely manner.

Requirements

• Minimum Bachelor’s degree in chemistry, chemical engineering, pharmaceutical science, or related field required. Master’s or PhD preferred.
• Minimum of 15 years of pharmaceutical industry experience in Oligonucleotide synthesis and purification at large scale.
• Experience managing a team of process development SMEs.
• Expertise in Oligonucleotide process development, manufacture, scale-up, and technology transfer.
• Prior experience in clinical Phase 3/commercial readiness process development and manufacturing.
• Experience working with third-party CMOs.
• Experience in GMP manufacturing and a strong understanding of US, EU, and JP regulations are required.
• Prior IND and BLA/NDA filing experience.
• Knowledge of cGMP, ICH, FDA, and EMA guidelines regarding Oligonucleotides.
• Proven track record of effective internal and external collaboration.

Benefits

• The base salary range for this role is $256,500 - $283,500.
• Avidity offers competitive compensation and benefits, including annual and spot bonuses, stock options, and RSUs.
• A commitment to learning and development, including job-specific training and an education reimbursement program.