Associate Director, Drug Product Development & Manufacturing
Avidity Biosciences, Inc., San Diego, TX, United States
Profoundly Improve People’s Lives by Revolutionizing the Delivery of RNA Therapeutics
At Avidity Biosciences, we believe that every employee contributes to our vision of improving people’s lives by delivering a new class of RNA therapeutics. Avidity is pioneering the field with its proprietary Antibody Oligonucleotide Conjugates (AOCs), combining the specificity of monoclonal antibodies with the precision of oligonucleotide therapies to tackle targets and diseases previously unreachable by existing RNA therapies.
The Opportunity We are seeking an
Associate Director of Drug Product Process Development and Manufacturing
who is experienced, knowledgeable, highly energetic, and self‑motivated. The position will lead all aspects of non‑GMP and GMP drug product development and manufacturing at external CMOs, oversee internal process development laboratory capability, and ensure robust development data packages for regulatory submissions.
What You Will Contribute
Subject matter expert on and lead for drug product development and clinical manufacturing projects, including cross‑functional team leadership.
Work with CMOs and QA to ensure timely release of drug product.
Spearhead and direct junior team members’ daily activities, including composition, technical review, and technical approval of drug product manufacturing documents such as batch records, deviations, change controls, and non‑conformance investigations.
Coordinate with CMOs, QA, and supply chain to ensure timely delivery of drug substance to drug product sites.
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.
Work with QC to support specification setting and ensure expiry and retest dating align with the drug product supply plan.
Lead technology transfer activities between CMOs 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; including process characterization studies, container closure selection, freeze/thaw studies, lyophilization cycle development, product process qualification, filter validation, etc.
Supervise direct reports and develop them for career progression.
Stay current on applicable regulations (FDA, EMA, ICH, GCP, GMP, Avidity policies) and ensure GxP and SOP training tasks, including GDPR data privacy, are completed on time.
What We Seek
Ph.D. in pharmaceutical sciences/engineering or similar with at least 5 years of relevant experience; or M.S./B.S. in a related scientific/engineering field with 10–15 years of experience.
Experience in biologics drug product GMP manufacturing and pharmaceutical unit operations, and knowledge of U.S., EU, and ICH regulations.
Experience working with third‑party CMOs preferred.
Experience with aseptic filling and operations, including lyophilization, and with combination products such as syringes or cartridges is a plus.
Experience managing, supervising, or mentoring junior associates.
Ability to multi‑task, adapt to changing priorities, and work in a fast‑paced environment.
Self‑motivated with minimal oversight on day‑to‑day activities.
Ability to build alignment, foster collaboration, and drive shared ownership across functions in a complex, matrixed environment.
Willingness to travel up to 20%.
Demonstrated curiosity and openness to integrating AI‑powered tools to enhance processes and data‑informed decisions.
What We Will Provide To You
The base salary range for this role is $119,700–$222,300, with final compensation commensurate with experience, skillset, and market factors.
Avidity offers competitive benefits, including bonus potential, a 401(k) with employer match, medical, dental, vision, LTD coverage, and four weeks of paid time off.
Additional Details
Title:
Associate Director, Drug Product Process Development and Manufacturing
Location:
Hybrid
Position Type:
Full Time / Exempt
Department:
Process Development – Drug Product
ID:
3105‑2026‑1/3105‑2026‑N1
#J-18808-Ljbffr
At Avidity Biosciences, we believe that every employee contributes to our vision of improving people’s lives by delivering a new class of RNA therapeutics. Avidity is pioneering the field with its proprietary Antibody Oligonucleotide Conjugates (AOCs), combining the specificity of monoclonal antibodies with the precision of oligonucleotide therapies to tackle targets and diseases previously unreachable by existing RNA therapies.
The Opportunity We are seeking an
Associate Director of Drug Product Process Development and Manufacturing
who is experienced, knowledgeable, highly energetic, and self‑motivated. The position will lead all aspects of non‑GMP and GMP drug product development and manufacturing at external CMOs, oversee internal process development laboratory capability, and ensure robust development data packages for regulatory submissions.
What You Will Contribute
Subject matter expert on and lead for drug product development and clinical manufacturing projects, including cross‑functional team leadership.
Work with CMOs and QA to ensure timely release of drug product.
Spearhead and direct junior team members’ daily activities, including composition, technical review, and technical approval of drug product manufacturing documents such as batch records, deviations, change controls, and non‑conformance investigations.
Coordinate with CMOs, QA, and supply chain to ensure timely delivery of drug substance to drug product sites.
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.
Work with QC to support specification setting and ensure expiry and retest dating align with the drug product supply plan.
Lead technology transfer activities between CMOs 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; including process characterization studies, container closure selection, freeze/thaw studies, lyophilization cycle development, product process qualification, filter validation, etc.
Supervise direct reports and develop them for career progression.
Stay current on applicable regulations (FDA, EMA, ICH, GCP, GMP, Avidity policies) and ensure GxP and SOP training tasks, including GDPR data privacy, are completed on time.
What We Seek
Ph.D. in pharmaceutical sciences/engineering or similar with at least 5 years of relevant experience; or M.S./B.S. in a related scientific/engineering field with 10–15 years of experience.
Experience in biologics drug product GMP manufacturing and pharmaceutical unit operations, and knowledge of U.S., EU, and ICH regulations.
Experience working with third‑party CMOs preferred.
Experience with aseptic filling and operations, including lyophilization, and with combination products such as syringes or cartridges is a plus.
Experience managing, supervising, or mentoring junior associates.
Ability to multi‑task, adapt to changing priorities, and work in a fast‑paced environment.
Self‑motivated with minimal oversight on day‑to‑day activities.
Ability to build alignment, foster collaboration, and drive shared ownership across functions in a complex, matrixed environment.
Willingness to travel up to 20%.
Demonstrated curiosity and openness to integrating AI‑powered tools to enhance processes and data‑informed decisions.
What We Will Provide To You
The base salary range for this role is $119,700–$222,300, with final compensation commensurate with experience, skillset, and market factors.
Avidity offers competitive benefits, including bonus potential, a 401(k) with employer match, medical, dental, vision, LTD coverage, and four weeks of paid time off.
Additional Details
Title:
Associate Director, Drug Product Process Development and Manufacturing
Location:
Hybrid
Position Type:
Full Time / Exempt
Department:
Process Development – Drug Product
ID:
3105‑2026‑1/3105‑2026‑N1
#J-18808-Ljbffr