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Senior Director, External Manufacturing Operations Job Title

Senior Director, External Manufacturing Operations

Location:

San Diego, CA / Hybrid / Remote (US Based)

Flsa

Position type:

Full time

Exempt

Department

Finance ID:

Tech Dev

8400-Q224-3

Profoundly Improve People’s lives by Revolutionizing the Delivery of RNA Therapeutics

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 and engage with us on LinkedIn and X.

The Opportunity

We are seeking a dynamic and experienced Senior Director of External Manufacturing Operations to lead and expand our external manufacturing capabilities. This role is critical in ensuring the seamless transition from clinical to commercial manufacturing, managing complex biologics production, and fostering high-performing partnerships with Contract Development and Manufacturing Organizations (CDMOs).

You will lead a team of Operations Managers to oversee strategic manufacturing partnerships, and ensure operational excellence, regulatory compliance, and supply continuity for our innovative AOC therapeutics.

What You Will Contribute

Manufacturing Operations & Supplier Relationship Management

Develop and execute Avidity’s external manufacturing strategy aligned with business goals. Lead the implementation of the External Manufacturing Operating Model (e.g., Virtual Plant Teams) to ensure cross-functional collaboration and operational consistency. Oversee the scale-up of manufacturing processes from clinical to commercial stages. In partnership with Global Supply Chain and Technical Product Management, ensure the right product is manufactured at the right time, in sufficient quantities per the S&OP process. In partnership with Technical Development, Quality and Technical Product Management ensure successful technology transfers from internal Technical Product Teams to external manufacturers and between manufacturing sites. Build and lead a high-performing team of Operations Managers to manage CDMO relationships. Contribute to CDMO selection process, contract negotiations, and performance governance. Establish and monitor KPIs, ensuring contract compliance and timely issue resolution. Collaborate with Procurement, Quality, and Regulatory teams to ensure alignment and compliance.

Operational Excellence & Compliance

Ensure all manufacturing activities meet global regulatory standards (FDA, EMA, cGMP). Drive continuous improvement initiatives in partnership with Technical Development and Product Management. Develop and maintain business continuity plans with CDMOs. Support quality audits, risk assessments, and continuous improvement programs.

Cross-Functional Collaboration

Partner with all Tech Ops functions and business partners to align manufacturing operations with strategic objectives. Represent External Manufacturing Operations in cross-functional meetings and strategic planning sessions. Foster a culture of accountability, collaboration, and innovation.

Financial Oversight

Manage and monitor CDMO budgets, ensuring alignment with fiscal forecasts and long-term plans. Ensure timely and accurate processing of purchase orders and vendor payments.

What We Seek

Bachelor’s degree in a scientific or engineering discipline; advanced degree (MBA, MS) preferred. 12+ years of experience in biopharmaceutical manufacturing, including biologics or complex modalities. Proven leadership in managing CDMO relationships, tech transfers, and global manufacturing operations. Strong understanding of global regulatory and quality standards. Demonstrated ability to lead cross-functional teams and drive strategic initiatives. Excellent communication, negotiation, and conflict resolution skills. Willingness to travel 25–50% as needed.

What We Will Provide To You

The base salary range for this role is $235k - $305k. 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 include 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.

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