Sr. Mgr/Associate Director AOC Process 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 Sr. Mgr/Associate Director AOC Process Development and Manufacturing to manage all aspects of non-GMP and GMP drug substance manufacturing including the scale-up to Phase 3 and commercial.  A strong knowledge of bioconjugation chemistry, purification techniques and analytical methods is required as well as a working knowledge of cGMP and FDA/EMA guidelines.  The Sr. Mgr/Associate Director AOC Process Development and Manufacturing will be responsible for authoring and reviewing module 3 IND sections as well as BLA sections related to AOC manufacture as well as leading our tech transfer and scale-up activities for all of Avidity’s drug substance manufacture.

Essential Duties and Responsibilities  

• Assume technical responsibility for Avidity’s drug substance CMOs and provide subject matter expert (SME) guidance for drug substance process development and scale-up. Responsible for developing and executing late-stage manufacturing strategy to meet Avidity’s advancing clinical pipeline.
• Work with CMOs and QA to ensure timely release of DS.
• Work with QC, QA and Analytics & Formulations to refine drug substance specifications for late-stage clinical trials and commercialization.
• Work with CMOs, QA and supply chain to ensure timely delivery of drug substance to drug product sites.
• Perform SME review of DS batch records.
• Provide Person-In-Plant support for DS manufacturing runs.
• Author relevant sections of Regulatory filings including INDs, IND amendments and BLAs. Coordinate DS vendor regulatory support as needed and ensure communication between Avidity RA and DS CMOs.
• Work with the QC stability team to ensure that AOC shelf-life extensions are executed in a timely manner. Provide SME oversight of drug substance stability program.  
• Manage drug substance tech transfer activities between CMOs and/or within CMOs for scale-up.
• Work with Analytics & Formulations team to design and manage drug substance development studies supporting commercial launch.
• Manage technical review of AOC OOS, OOT, deviations, change controls and, nonconformance investigations.
• Identify and communicate risks to clinical programs due to manufacturing delays.
• Participate in developing appropriate risk mitigation strategies for AOC supply.
• Ensure adherence to applicable regulations including FDA, EMA, ICH, GCP, GMP and Avidity policies and procedures.

Qualifications

• Minimum Bachelor’s degree in chemistry, pharmaceutical science, or related field required.
• Minimum of 10 years of pharmaceutical industry experience in antibody drug conjugates with 6 years in a leadership role. Expertise in scale-up and technology transfer.
• Prior experience in clinical Phase 3 manufacturing with knowledge of QA and Regulatory requirements for late-stage clinical and commercial manufacturing.
• Experience in GMP manufacturing required, along with strong understanding of US, EU and JP regulations.
• Prior IND and BLA filing experience is required.
• Experience working with third-party CMOs required.
• Knowledge of cGMP, ICH, FDA, EMA guidelines regarding drug substance
• 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.