Director, Technical Product Lead

Avidity Biosciences Inc

2d • $209,000 - $231,000 • 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%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%2525252526a%252525253DTwitter%25252526a%2525253DTwitter%252526a%25253DTwitter%2526a%253DTwitter%26a%3DTwitter&a=Twitter].

The Avidity team is seeking an experienced and driven Director, Technical Product Lead (TPL) to lead cross-functional teams that are accountable for chemistry, manufacturing, and controls (CMC) product lifecycle management. This individual will serve as the single point of accountability for all CMC activities, from early development through regulatory approval and commercial lifecycle management. This individual will play a central role in shaping the technical and operational direction of their assigned programs. The TPL role is a highly visible matrix team leader that provides strategic and technical leadership within Technical Operations to the CMC teams, while representing Tech Ops on Global Program Teams.

The ideal candidate will possess strong knowledge of CMC leadership with deep technical understanding of Biologics, Oligonucleotide and/or Bioconjugation process development, analytical methods, tech transfer, manufacturing, CMC regulatory strategy and Agency interactions. Additionally, this individual should possess strong interpersonal communication skills, high emotional intelligence, and be fluent in the art of negotiation.

Requirements

• Bachelor's degree in biochemistry, chemical engineering, pharmaceutical sciences, or a related field required; advanced degree (MS or PhD) strongly preferred.
• Minimum 10–15 years of progressive industry experience in CMC development, with breadth across two or more technical functions (e.g., process development, analytical development, manufacturing, regulatory CMC, or quality).
• Minimum 5 years of leadership experience within a CMC function in biologics, oligonucleotides, or advanced therapeutics.
• Demonstrated experience leading late-stage development through commercial launch, with deep knowledge of process and analytical method development, and validation lifecycles.
• Strong working knowledge of QA and regulatory requirements for late-stage clinical and commercial manufacturing, including cGMP, ICH, FDA, and EMA guidelines.
• Broad understanding of CMC development and compliance requirements across analytics, process development, manufacturing, regulatory CMC, and quality assurance.
• Proven track record of leading and aligning cross-functional technical teams in a matrixed organization.
• Proven experience authoring and leading CMC sections of global regulatory submissions, including INDs/IMPDs, BLAs/MAAs/JNDAs, and post-approval filings.
• Excellent communication and interpersonal skills, with demonstrated ability to facilitate. constructive problem-solving and drive decisions across functions and organizational levels
• Ability to manage multiple priorities, navigate ambiguity, and work effectively in a fast-paced, dynamic environment.

Responsibilities

• Provide technical and strategic leadership to cross-functional CMC development teams accountable for one or more early- and late-phase programs.
• Build and maintain a long-term development, manufacturing, and supply strategy for assigned programs, encompassing early- and late-stage CMC development, process validation, commercial readiness, product launch, and post-approval lifecycle management.
• Partner with Manufacturing and Supply Chain to ensure manufacturing capacity and network strategies are in place to meet clinical and commercial demand.
• Identify and lead the assessment of technical, regulatory, quality, logistical, and financial risks associated with CMC development, manufacture, and supply, and develop corresponding mitigation strategies.
• Represent Technical Operations and the CMC team on Global Program Teams for assigned products, serving as the primary CMC voice in cross-functional program governance.
• Develop long-range technical strategies to enable CMC delivery against Global Program Team objectives.
• Lead commercial product CMC lifecycle activities, including post-approval change management, product risk management, robustness improvements, and continuous improvement initiatives.
• Drive the creation of integrated commercial readiness plans to enable global regulatory submissions and product launches.
• Cross-functional review and approval of critical product related documents including: IND/IMPD, BLA/MAA, meeting briefing documents and other regulatory documents Scale up and tech transfer protocols Pharmacy Manual Comparability plans/reports Justification of Specifications Process Characterization and Validation documentation Commercial Process Control Strategy
• Present technical product strategies at technical and program governance forums.
• Author and review relevant sections of Regulatory filings, including INDs, IND amendments, and BLAs.
• Provide coaching and mentoring to CMC core team members.

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: Director
• Number of Employees: 101-250 employees