Manager, Drug Product Development And Manufacturing

Company Overview

At Avidity Biosciences, we are passionate about the impact of every employee in bringing potentially life-changing therapeutics to patients in need. Avidity is pioneering a new class of oligonucleotide-based therapies called AOCs, designed to overcome the current limitations of oligonucleotide therapies to treat a wide range of serious diseases. We utilize our proprietary AOC platform to design, engineer and develop transformative therapeutics that combine the tissue selectivity of monoclonal antibodies (mAbs) and the precision of oligonucleotide-based therapies to access previously undruggable tissue and cell types and more effectively target underlying genetic drivers of diseases. If you are a committed, solution-oriented thinker, come make a difference with us.

Job Summary

We are seeking a Manager Drug Product Development and Manufacturing who is experienced, highly energetic, and self-motivated. The individual will be responsible for working with existing and new drug product presentations to ensure on-time delivery of drug product supplies and robust development data packages for regulatory submissions. In addition, the Manager Drug Product Development and Manufacturing will support all aspects of non-GMP and GMP drug product manufacturing and ensure that the CMC team is aligned with the manufacturing strategy at each CMO. A strong knowledge of sterile parenteral filling and technical transfer activities is required as well as a working knowledge of cGMP and FDA/EMA guidelines. The Manager Drug Product Development and Manufacturing will support the authoring and reviewing of module 3 IND and BLA sections related to drug product. Experience with liquid and lyophilized biologics is required and frozen formulations is preferred.

Essential Duties and Responsibilities

• Work with CMOs, QA and supply chain to ensure timely delivery of drug substance to drug product sites in time for DP manufacturing.
• Manage tech transfer activities between CMOs and/or within CMOs for scale-up of new or existing drug products.
• Provide Person-In-Plant support for drug product manufacturing runs and complete technical review of batch records.
• 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.
• Support process performance qualification studies and commercialization including secondary packaging.
• Lead or support characterization container closure selection, leachable/extractables, freeze/thaw studies, photo degradation, and other BLA-enabling work. Occasional laboratory work may be required.
• Manage daily technical activities for Avidity’s drug product CMOs related to clinical and commercial drug product lifecycle management programs, which will include cross-functional alignment.
• Ensure adherence to applicable regulations including FDA, EMA, ICH, GCP, GMP and Avidity policies and procedures.
• Spearhead technical review of drug product executed batch records, deviations, change controls, nonconformance investigations, etc.
• 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 container closure selection, leachable/extractables, freeze/thaw studies, photo degradation, and other BLA-enabling work. Occasional laboratory work may be required.
  • Support process performance qualification studies and commercialization including secondary packaging.
• Work with CMOs and QA to ensure timely release of DP.
  • Spearhead technical review of drug product executed batch records, deviations, change controls, nonconformance investigations, etc.

Qualifications

• Experience in GMP manufacturing required, along with strong understanding of US and EU regulations.
• Experience using statistical tools and software preferred.
• Excellent communication and interpersonal skills and the ability to facilitate constructive, expedient problem-solving.
• Proven track record of effective internal and external collaboration.
• Basic understanding of formulation and compendial drug product analytical methods required.
• Experience working with third-party CMOs required.
• Ability to multi-task, manage conflict, and work in a fast-paced environment.
• Minimum 7+ years with BS or minimum 5+ years with PhD in pharmaceutical sciences, engineering, or related field required.
• Knowledge of cGMP, ICH, FDA, EMA guidelines regarding drug product supply.

Salary range - $135,000 - $158,000 Salary commensurate with experience