What are the responsibilities and job description for the Assoc Dir, Analytical Development (Oligonucleotide) position at Avidity Biosciences Inc?
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 Associate Director to join the Analytical Development group who is experienced and committed to developing and running oligonucleotide methods to support our AOC research and clinical programs. This is a hands-on position with responsibilities that require working with contract manufacturing organizations, cross-functional teams, and key stakeholders.
What You Will Contribute
- Defines the analytical strategy for early- and late-stage oligonucleotide programs, ensuring phase-appropriate development, control strategies, and lifecycle management from preclinical through commercialization.
- Provides strategic oversight for method development, transfer, qualification, validation, reference standard qualification, forced degradation studies, stability strategy, and impurity characterization across programs.
- Serves as subject matter expert (SME) in nucleic acid chemistry and oligonucleotide analytical technologies, including IP-RP-UPLC (denaturing and non-denaturing), AEX, HILIC, and orthogonal separation approaches.
- Establishes and oversees advanced mass spectrometry strategies for oligonucleotide characterization and impurity identification (e.g., Orbitrap, QQQ, Single Quad).
- Supports analytical control strategies for identity, purity, assay, content, residual solvents, and degradation products to support release and stability specifications.
- Provides leadership and oversight of external CROs and CDMOs, ensuring high-quality execution of method development, qualification, validation, transfer, and GMP release testing.
- Accountable for review and approval of analytical protocols, validation reports, regulatory documentation, and data packages to ensure scientific rigor, data integrity, and compliance.
- Drives innovation in analytical platforms, implementing novel technologies and continuous improvement initiatives to address emerging challenges in oligonucleotide characterization.
- Authors and provides strategic review of analytical sections for regulatory submissions (IND, CTA, BLA/NDA), and leads responses to health authority inquiries.
- Ensures adherence to global regulatory requirements (FDA, EMA, ICH, GMP) and internal quality systems, proactively identifying compliance risks and mitigation strategies.
- Builds, mentors, and develops high-performing analytical teams to support in-house method development and characterization activities.
- Embodies and reinforces the company's core values, promoting an agile, visionary, integrated, and inclusive culture.
What We Seek
- Minimum PhD in chemistry, biology, biochemistry, pharmaceutical sciences, with 8 years of pharmaceutical industry experience or BS/MS degree with 15 years of industry experience.
- Deep expertise in analytical characterization of synthetic oligonucleotides, including chromatographic separations (IP-RP-UPLC, AEX, HILIC) and MS-based structural elucidation.
- Strong understanding of impurity profiling of oligonucleotide therapeutics.
- Extensive knowledge of analytical method lifecycle management, including development, qualification, validation, transfer, and comparability.
- Strong working knowledge of ICH guidelines and global regulatory expectations for oligonucleotide products.
- Experience defining control strategies and establishing phase-appropriate specifications.
- Proven experience authoring and reviewing analytical sections of IND/CTA filings; BLA/NDA experience preferred.
- Experience leading analytical responses to regulatory agency questions.
- Demonstrated success overseeing CDMOs/CROs.
- Experience building, mentoring, and developing scientific teams (direct people management preferred)
What We Will Provide To You
- The base salary range for this role is $175,750 - $194,250. 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 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.
Additional Details
Title: Associate Director, Analytical Development (Oligonucleotide)
Location: San Diego, CA, Onsite
Position Type: Full Time / Exempt
Department: Analytical Development & Formulation
ID: 3105-2026-N1
#LI-Onsite
Salary : $175,750 - $194,250