Director Drug Product Supply

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 Director Drug Product Supply who is experienced, highly energetic, and s individual will be responsible for working with the clinical development teams to determine study drug requirements and developing the manufacturing plans to support each study.  In addition, the Director Drug Product Supply will manage 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 sterile parenteral filling and the requirements of clinical supply is required as well as a working knowledge of cGMP and FDA/EMA guidelines.  The Director Drug Product Supply will be responsible for authoring and reviewing module 3 IND sections related to drug product.

Essential Duties and Responsibilities  

• Assume technical responsibility for Avidity’s drug product CMOs and provide subject matter expert (SME) guidance for drug product manufacturing.
• Work with CMOs and QA to ensure timely release of DP.
• Work with QC, QA and Analytics & Formulations to refine drug product specifications as programs advance through clinical development.
• 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 drug product tech transfer activities between CMOs and/or within CMOs for scale-up.

• Work with Analytics & Formulations team to design and manage drug product development studies supporting clinical advancement and eventual commercialization; includes lyophilization cycle development work at CMOs, process scale-up work, commercial container closure selection, leachable/extractables, freeze/thaw studies, photo degradation and other BLA-enabling work.
• Manage technical review of drug product OOS, OOT, deviations, change controls, nonconformance investigations, etc.

• Identify and communicate risks to clinical programs due to manufacturing delays.
• Participate in developing appropriate risk mitigation strategies for DP supply.

• Ensure adherence to applicable regulations including FDA, EMA, ICH, GCP, GMP and Avidity policies and procedures.

Qualifications

• Minimum Bachelor’s degree in supply chain, pharmaceutical sciences, engineering, or related field required.

• Minimum of 10 years of pharmaceutical industry experience in drug product manufacturing with 6 years in a leadership role.
• Experience in GMP manufacturing required, along with strong understanding of US, EU and JP 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.