Avidity Biosciences - San Diego, CA
posted 2 months ago
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.