Manager, Drug Product Development & Manufacturing
Avidity Biosciences - San Diego, CA
posted 6 months ago
About the position
The Manager, Drug Product Development & Manufacturing at Avidity Biosciences is a pivotal role that focuses on the development and manufacturing of drug products, particularly in the context of RNA therapeutics. This position is designed for an experienced, energetic, and self-motivated individual who will be responsible for ensuring robust development data packages for regulatory submissions related to both existing and new drug products. The Manager will support all aspects of non-GMP and GMP drug product manufacturing, ensuring that the Chemistry, Manufacturing, and Controls (CMC) team is aligned with the manufacturing strategy at each Contract Manufacturing Organization (CMO). A strong understanding of sterile parenteral filling and the requirements of clinical supply manufacturing is essential, along with a working knowledge of current Good Manufacturing Practices (cGMP) and FDA/EMA guidelines. In this role, the Manager will manage daily technical activities for Avidity's drug product CMOs, which may include leading cross-functional teams. Responsibilities will include working closely with CMOs and Quality Assurance (QA) to ensure the timely release of drug products, spearheading technical reviews of executed batch records, deviations, change controls, and nonconformance investigations. The Manager will also be responsible for identifying and communicating risks to clinical programs due to manufacturing delays, ensuring adherence to applicable regulations, and providing Person-In-Plant support during drug product manufacturing runs. Additionally, the Manager will coordinate regulatory support for drug product vendors and ensure effective communication between Avidity's Regulatory Affairs (RA) and drug product CMOs. The position requires a proactive approach to managing tech transfer activities between CMOs and/or within CMOs for the scale-up of new or existing drug products. The Manager will lead or support characterization, validation, and comparability studies, which include process characterization studies, container closure selection, leachable/extractables, freeze/thaw studies, photo degradation, and product process qualification. This role is critical in supporting Avidity's mission to deliver innovative RNA therapeutics that profoundly improve patients' lives.
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 products.
- 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 drug product 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 drug product vendor regulatory support and ensure communication between Avidity RA and drug product 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 7+ years with BS or minimum 5+ years with PhD 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
- Wellness program
- Stock options
- Health insurance
- Dental insurance
- RSU
- Tuition reimbursement
- On-the-job training
- Vision insurance
- 401(k) matching
