Manager, Oligonucleotide Manufacturing - Remote

Overview

The Manager of Oligonucleotide Manufacturing will play a key role in supporting clinical and commercial manufacturing processes at Avidity Biosciences, focusing on oligonucleotide therapies.

In Short

• Manage oligonucleotide manufacturing processes and provide SME guidance.
• Review master and executed batch records.
• Support tech transfer documentation and ensure successful process transfers.
• Provide person-in-plant support during manufacturing runs.
• Collaborate with CMOs, QA, and Supply Chain for timely delivery of oligonucleotides.
• Support drug substance team as needed.
• Assist with regulatory filings including INDs and BLAs.
• Ensure compliance with FDA, EMA, and ICH regulations.
• Conduct PMI and COGM assessments.
• Refine oligonucleotide specifications for trials and commercialization.

Requirements

• Bachelor’s or Master’s degree in Chemistry, Biochemistry, or related field.
• 7+ years of relevant industry experience in oligonucleotide manufacturing.
• Experience with large-scale oligonucleotide synthesis and purification.
• Hands-on GMP manufacturing experience.
• Prior experience in clinical pivotal/commercial readiness.
• Experience in IND and BLA filings.
• Familiarity with PMI and COGM evaluation tools.
• Experience working with third-party CMOs.
• Strong collaboration and communication skills.
• Detail-oriented and able to manage conflict in fast-paced environments.

Benefits

• Base salary range: $142,500 - $157,500.
• Opportunities for bonuses, stock options, and RSUs.
• 401(k) with employer match.
• Comprehensive wellness program including medical, dental, and vision coverage.
• Four weeks of paid time off.
• Commitment to learning and development with training programs.