Assoc Dir, Drug Product Dev & Mfg

Avidity Biosciences Inc

21d • Hybrid

About The Position

At Avidity Biosciences, 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.

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. For more information about our AOC platform, clinical development pipeline, and people, please visit www.aviditybiosciences.com [https://c212.net/c/link/?t=0&l=en&o=3867927-1&h=540455448&u=http%3A%2F%2Fwww.aviditybiosciences.com%2F&a=www.aviditybiosciences.com] and engage with us on LinkedIn [https://c212.net/c/link/?t=0&l=en&o=3867927-1&h=3458955515&u=https%3A%2F%2Fc212.net%2Fc%2Flink%2F%3Ft%3D0%26l%3Den%26o%3D3849311-1%26h%3D1532752011%26u%3Dhttps%253A%252F%252Fc212.net%252Fc%252Flink%252F%253Ft%253D0%2526l%253Den%2526o%253D3824048-1%2526h%253D1295074681%2526u%253Dhttps%25253A%25252F%25252Fc212.net%25252Fc%25252Flink%25252F%25253Ft%25253D0%252526l%25253Den%252526o%25253D3758964-1%252526h%25253D1535717129%252526u%25253Dhttps%2525253A%2525252F%2525252Fc212.net%2525252Fc%2525252Flink%2525252F%2525253Ft%2525253D0%25252526l%2525253Den%25252526o%2525253D3701287-1%25252526h%2525253D2046811440%25252526u%2525253Dhttps%252525253A%252525252F%252525252Fc212.net%252525252Fc%252525252Flink%252525252F%252525253Ft%252525253D0%2525252526l%252525253Den%2525252526o%252525253D3640662-1%2525252526h%252525253D3325811211%2525252526u%252525253Dhttps%25252525253A%25252525252F%25252525252Fc212.net%25252525252Fc%25252525252Flink%25252525252F%25252525253Ft%25252525253D0%252525252526l%25252525253Den%252525252526o%25252525253D3245424-1%252525252526h%25252525253D2320056573%252525252526u%25252525253Dhttps%2525252525253A%2525252525252F%2525252525252Fwww.linkedin.com%2525252525252Fcompany%2525252525252Favidity-biosciences-llc%252525252526a%25252525253DLinkedIn%2525252526a%252525253DLinkedIn%25252526a%2525253DLinkedIn%252526a%25253DLinkedIn%2526a%253DLinkedIn%26a%3DLinkedIn&a=LinkedIn] and X [https://c212.net/c/link/?t=0&l=en&o=3867927-1&h=2735291290&u=https%3A%2F%2Fc212.net%2Fc%2Flink%2F%3Ft%3D0%26l%3Den%26o%3D3849311-1%26h%3D2118106899%26u%3Dhttps%253A%252F%252Fc212.net%252Fc%252Flink%252F%253Ft%253D0%2526l%253Den%2526o%253D3824048-1%2526h%253D3108175851%2526u%253Dhttps%25253A%25252F%25252Fc212.net%25252Fc%25252Flink%25252F%25253Ft%25253D0%252526l%25253Den%252526o%25253D3758964-1%252526h%25253D2598500994%252526u%25253Dhttps%2525253A%2525252F%2525252Fc212.net%2525252Fc%2525252Flink%2525252F%2525253Ft%2525253D0%25252526l%2525253Den%25252526o%2525253D3701287-1%25252526h%2525253D1697374436%25252526u%2525253Dhttps%252525253A%252525252F%252525252Fc212.net%252525252Fc%252525252Flink%252525252F%252525253Ft%252525253D0%2525252526l%252525253Den%2525252526o%252525253D3640662-1%2525252526h%252525253D4275741626%2525252526u%252525253Dhttps%25252525253A%25252525252F%25252525252Fc212.net%25252525252Fc%25252525252Flink%25252525252F%25252525253Ft%25252525253D0%252525252526l%25252525253Den%252525252526o%25252525253D3245424-1%252525252526h%25252525253D2028016135%252525252526u%25252525253Dhttps%2525252525253A%2525252525252F%2525252525252Ftwitter.com%2525252525252Faviditybio%252525252526a%25252525253DTwitter%2525252526a%252525253DTwitter%25252526a%2525253DTwitter%252526a%25253DTwitter%2526a%253DTwitter%26a%3DTwitter&a=Twitter].

We are seeking an Associate Director of Drug Product Process Development and Manufacturing who is experienced, knowledgeable, highly energetic, and self-motivated. The individual will be working with and engaging in cross functional project teams on existing and new drug products to ensure robust development data packages for regulatory submissions. This position will lead all aspects of non-GMP and GMP drug product development and manufacturing at external CMOs. In addition, internal process development laboratory capability are planned for future growth. A strong knowledge of sterile parenteral filling and the requirements of clinical supply manufacturing is required as well as demonstrated experience in adherence to cGMP and FDA/EMA guidelines.

Requirements

• Ph.D. in pharmaceutical sciences/engineering or similar with at least 5 years relevant experience; or MS/BS in related scientific/engineering field with at least 10-15 years experience.
• Experience in biologics drug product GMP manufacturing and pharmaceutical unit operations required, along with understanding of US, EU, and ICH regulations and guidelines.
• Experience working with third-party CMOs preferred.
• Experience with aseptic filling and operations, including lyophilization, and with combination products such as syringes or cartridges a plus.
• Experience managing, supervising, or mentoring junior associates.
• Ability to multi-task, adapt to changing priorities, and work in a fast-paced environment.
• Must be a self-motivated individual requiring little oversight on day-to-day activities.
• Ability to build alignment, foster collaboration, and drive shared ownership across functions to achieve results in a complex, matrixed environment.
• Ability to travel as required up to 20%.
• Demonstrated curiosity and openness to integrating AI-powered tools to enhance functional processes, support data-informed decisions, and drive innovative outcomes across teams.

Responsibilities

• Subject matter expert on and lead for drug product development and clinical manufacturing projects, as applicable, which will include cross-functional team leadership.
• Work with CMOs and QA to ensure timely release of DP.
• Spearhead, and direct junior team members’ daily activities including composition, technical review, and technical approval of drug product manufacturing documents including, but not limited to, executed batch records, deviations, change controls, nonconformance investigations, etc.
• 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 development and manufacturing runs.
• Provide CMC support for regulatory filings including INDs, IND amendments and NDA/BLAs as needed.
• Work with QC team to support specification setting and to ensure that expiry and retest dating is current and fully aligned with the drug product supply plan.
• Lead tech transfer activities between CMOs and/or within CMOs for scale-up of new or existing drug products.
• Design, lead, and manage development, characterization, and validation studies, and support comparability studies; includes process characterization studies, container closure selection, freeze/thaw studies, lyophilization cycle development, product process qualification, filter validation, etc.
• Supervise direct reports and develop them to progress in their position.
• Keep abreast of and ensure adherence to applicable regulations including FDA, EMA, ICH, GCP, GMP and Avidity policies and procedures. Ensure GxP and SOP training tasks, including GDPR data privacy training, are completed in a timely manner.

Benefits

• Avidity offers competitive compensation and benefits, which includes the opportunity for annual bonus 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Ph.D. or professional degree
• Number of Employees: 101-250 employees