Associate Director, Process Development and Manufacturing

If you are unable to complete this application due to a disability, contact this employer to ask for an accommodation or an alternative application process. Associate Director, Process Development and Manufacturing Full Time US 6 days ago Requisition ID: 1077 Salary Range: $119,700.00 To $222,300.00 Annually Profoundly Improve People’s lives by Revolutionizing the Delivery of RNA Therapeutics At Avidity Biosciences – A Novartis Company, we are passionate about the impact of every employee in realizing our vision of improving people’s lives by delivering a new class of RNA therapeutics. Avidity is revolutionizing the field of RNA with its proprietary AOCs, which are designed to combine the specificity of monoclonal antibodies with the precision of oligonucleotide therapies to address targets and diseases previously unreachable with existing RNA therapies. If you are a committed, solution‑oriented thinker, join us in making a difference and become part of our growing culture that is integrated, collaborative, agile and focused on the needs of patients. At Avidity Biosciences, Inc.'s mission is to profoundly improve people's lives by delivering a new class of RNA therapeutics - Antibody Oligonucleotide Conjugates (AOCs™). Utilizing its proprietary AOC platform, Avidity demonstrated the first-ever successful targeted delivery of RNA into muscle and is leading the field with clinical development programs for three rare muscle diseases: myotonic dystrophy type 1 (DM1), Duchenne muscular dystrophy (DMD) and facioscapulohumeral muscular dystrophy (FSHD). Avidity is broadening the reach of AOCs with its advancing and expanding pipeline, including programs in cardiology and immunology through internal discovery efforts and key partnerships. Avidity is headquartered in San Diego, CA. The Opportunity The Associate Director of AOC Process Development and Manufacturing – Bioconjugation is a senior leader accountable for managing all aspects of AOC drug substance (DS) process development and 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 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 DS manufacture and will lead our tech transfer and scale‑up activities for all of Avidity’s AOC DS manufacture. What You Will Contribute Assume technical responsibility for Avidity’s AOC DS CMO process development and manufacturing for one or more programs. Provide subject matter expert (SME) guidance for AOC DS process development, tech transfer activities between CMOs and/or within CMOs for scale‑up. Review batch records and provide SME guidance for deviations, investigations, change controls and preparation for manufacturing campaigns. Work with CMOs and QA to ensure timely release of AOC DS. Work with QC, QA and Analytics & Formulations to refine AOC DS specifications for late‑stage clinical trials and commercialization. Work with CMOs, QA and Supply Chain to ensure timely delivery of AOC DS to DP manufacturing sites. Provide Person‑In‑Plant support for AOC DS manufacturing runs. Author relevant sections of Regulatory filings including INDs, IND amendments and BLAs. Coordinate AOC DS vendor regulatory support as needed and ensure communication between Avidity RA and AOC DS CMOs. Work with the QC stability team to ensure that AOC DS shelf‑life extensions are executed in a timely manner. Provide SME oversight of AOC DS stability programs. Work with Analytics & Formulations team to design and manage AOC DS development studies supporting commercial launch. Support AOC DS process characterization, validation readiness and PPQ campaign execution. Develop and execute late‑stage manufacturing strategy to meet Avidity’s advancing pipeline. Identify and communicate risks to clinical programs and commercial supply chain due to manufacturing delays. Participate in developing appropriate risk mitigation strategies for AOC DS supply. Ensure adherence to applicable regulations including FDA, EMA, ICH, GCP, GMP and Avidity policies and procedures. What We Seek Minimum Bachelor's degree in chemistry, chemical engineering, pharmaceutical science, or related field. Master's or PhD preferred. Minimum of 8 years of pharmaceutical industry experience in antibody/protein bioconjugation, ideally with oligonucleotides. Expertise in bioconjugation process development and manufacture, scale‑up and technology transfer. Prior experience in clinical Phase 3/commercial readiness process development and manufacturing, Process Characterization and PPQ 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. Experience working with third‑party CDMOs. Prior IND and BLA/NDA filing experience. Experience working with third‑party CMOs. Knowledge of cGMP, ICH, FDA, EMA guidelines regarding ADCs, or similar platforms. 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. What We will Provide to You: The base salary range for this role is $119,700 to $222,300. The final compensation will be commensurate with such factors as relevant experience, skillset, internal equity and market factors. Avidity offers competitive compensation and benefits which includes the opportunity for annual and spot bonuses, stock options and RSUs, as well as a 401(k) with an employer match. In addition, the comprehensive wellness program includes coverage for medical, dental, vision, and LTD, and four weeks of time off. A commitment to learning and development which includes a variety of programming internally developed by and for Avidity employees, opportunities for job‑specific training offered by industry, and an education reimbursement program. #J-18808-Ljbffr