Manager, Drug Product Development & Manufacturing

$129,000 - $163,000/Yr

Avidity Biosciences - San Diego, CA

Full-time - Mid Level

San Diego, CA

Professional, Scientific, and Technical Services

About the position

At Avidity Biosciences, the Manager of Drug Product Development & Manufacturing plays a crucial role in the advancement of RNA therapeutics. This position is designed for an experienced, highly energetic, and self-motivated individual who will be responsible for overseeing the development of robust data packages for regulatory submissions related to drug products. The manager will work closely with both existing and new drug products, ensuring that all aspects of non-GMP and GMP drug product manufacturing are supported effectively. A strong understanding of sterile parenteral filling and the requirements of clinical supply manufacturing is essential, along with a working knowledge of cGMP and FDA/EMA guidelines. The role also involves authoring and reviewing module 3 IND and BLA sections related to drug products, ensuring compliance with regulatory standards. The Manager will manage daily technical activities for Avidity's drug product Contract Manufacturing Organizations (CMOs) related to clinical and commercial drug product lifecycle management programs. This includes leading cross-functional teams, ensuring timely release of drug products, and spearheading technical reviews of executed batch records, deviations, change controls, and nonconformance investigations. The manager will also identify and communicate risks to clinical programs due to manufacturing delays and ensure adherence to applicable regulations, including FDA, EMA, ICH, GCP, GMP, and Avidity policies and procedures. In addition, the Manager will provide Person-In-Plant support for drug product manufacturing runs, coordinate regulatory support for drug product vendors, and work with the QC stability team to ensure that expiry and retest dating aligns with the drug product supply plan. The role also involves managing tech transfer activities between CMOs and supporting characterization, validation, and comparability studies, which are critical for BLA-enabling work. This position is integral to Avidity's mission of improving lives through innovative RNA therapeutics, and it requires a commitment to collaboration, problem-solving, and effective communication.

Responsibilities

• Manage daily technical activities for Avidity's drug product CMOs related to clinical and commercial drug product lifecycle management programs, which may include cross-functional team leadership.
• Work with CMOs and QA to ensure timely release of drug product.
• Spearhead technical review of drug product executed batch records, deviations, change controls, nonconformance investigations, etc.
• Identify and communicate risks to clinical programs due to manufacturing delays.
• Ensure adherence to applicable regulations including FDA, EMA, ICH, GCP, GMP and Avidity policies and procedures.
• Work with CMOs, QA and supply chain to ensure timely delivery of drug substance to drug product sites in time for DP manufacturing.
• Provide Person-In-Plant support for drug product manufacturing runs.
• Provide CMC support for regulatory filings including INDs, IND amendments and NDA/BLAs as needed.
• Coordinate DP vendor regulatory support and ensure communication between Avidity RA and DP CMOs.
• Work with the QC stability team to ensure that expiry and retest dating is current and fully aligned with the drug product supply plan.
• Manage tech transfer activities between CMOs and/or within CMOs for scale-up of new or existing drug products.
• Lead or support characterization, validation, and comparability studies; includes process characterization studies, container closure selection, leachable/extractables, freeze/thaw studies, photo degradation, product process qualification, and other BLA-enabling work.

Requirements

• Minimum 5+ years with BS or PhD (preferred) in pharmaceutical sciences, engineering, or related field required.
• Experience in GMP manufacturing required, along with strong understanding of US and EU regulations.
• Experience working with third-party CMOs required.
• Knowledge of cGMP, ICH, FDA, EMA guidelines regarding drug product supply.
• 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.

Benefits

• Competitive compensation and benefits including annual and spot bonuses, stock options and RSUs, and a 401(k) with employer match.
• Comprehensive wellness program including coverage for medical, dental, vision, and LTD.
• Four weeks of time off.
• Commitment to learning and development with various programming and education reimbursement.