Associate Director, Drug Product Development & Manufacturing

About the role

The Associate Director of Drug Product Process Development and Manufacturing at Avidity Biosciences is responsible for leading drug product development and clinical manufacturing projects. This role involves cross-functional team leadership, ensuring timely release of drug products, directing junior team members, and providing technical support during drug product development and manufacturing runs.

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 Drug Products.
• 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.

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.

Qualifications

• 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.

Skills

• Strong knowledge of sterile parenteral filling and the requirements of clinical supply manufacturing.
• Adherence to cGMP and FDA/EMA guidelines.
• Leadership and supervisory skills.
• Technical writing and documentation skills.
• Collaboration and communication skills.
• Problem-solving and decision-making abilities.
• Knowledge of regulatory compliance and industry standards.

Benefits

• Comprehensive wellness program including coverage for medical, dental, vision, and LTD.
• Four weeks of time off.
• Annual bonus opportunity.
• 401(k) with an employer match.

Pay

The base salary range for this role is $119,700 - $222,300. The final compensation will be commensurate with such factors as relevant experience, skillset, internal equity and market factors.

Schedule

This role is currently hybrid, with the option to work from home or in the office. Travel may be required up to 20%.