Principal Scientist, Biologics Process Development

Avidity Biosciences Inc

6h•Remote

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%25252525253DLinkedIn%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%25252525253DTwitter%2525252526a%252525253DTwitter%25252526a%2525253DTwitter%252526a%25253DTwitter%2526a%253DTwitter%26a%3DTwitter&a=Twitter]. We are seeking a highly motivated and experienced downstream process development leader to support late-stage biologics programs through licensure and lifecycle management. This role will serve as the technical lead for downstream process development activities across clinical and commercial programs and will be accountable for process design, optimization, characterization, validation readiness, and regulatory authorship. This is a primarily hands-on role (approximately 70% technical execution / 30% strategic leadership) supporting monoclonal antibodies, antibody-related variants, and antibody-oligonucleotide conjugates. The successful candidate will operate as a key CMC contributor for BLA-stage programs and will play a central role in regulatory filings and health authority interactions. This position is structured as a flexible-level hire at either the Principal Scientist or Associate Director level, depending on experience. This is a high-impact role supporting late-stage biologics programs approaching commercialization. The individual will directly influence regulatory success, process robustness, and commercial readiness while remaining deeply engaged in technical execution. This role provides a strong platform for future leadership growth within Process Development.

Requirements

Ph.D. in Chemical Engineering, Biochemical Engineering, Bioengineering, or related field with5+ years of relevant experience OR M.S. with8+ years of experience OR B.S. with 12+ years of experience
Extensive experience in downstream process development for monoclonal antibodies or related biologics, including chromatography-based purification and filtration operations.
Experience with viral clearance strategies and regulatory expectations for viral safety.
Demonstrated experience supporting late-stage clinical programs and commercial readiness.
Direct authorship of CMC sections for IND and BLA submissions.
Experience defining CPPs and leading process characterization studies.
Strong understanding of scale-up, tech transfer, and process validation.
Experience supporting regulatory inspections or health authority interactions.
Proven troubleshooting skills in purification processes.
Deep technicalexpertisein downstream biologics processing
Strong regulatory writing and CMC strategy skills
Ability tooperateindependently in a fast-paced late-stage environment
Excellent cross-functional communication skills
Strategic thinking with hands-on execution capability
Strong problem-solving and data-driven decision-making skills
Ability to build alignment, foster collaboration, and drive shared ownership across functions to achieve results in a complex, matrixed environment.
Ability to travel to Avidity’s San Diego headquartersapproximately twiceper year for company development weeks and occasional in-person collaboration.
Demonstrated openness to adopting digital and AI-enabled tools that enhance data analysis, process understanding, and decision-making.

Nice To Haves

Experience with antibody variants or antibody-oligonucleotide conjugates.
Experience supporting CDMO manufacturing and technology transfer.
Experience supporting commercial manufacturing.
Experience in comparability assessments and post-approval change management.
Prior experience in a matrixed biotech environment.
Demonstrated ability to lead without formal authority.

Responsibilities

Serve as the technical lead for downstream process development from late clinical stage through commercialization.
Design,optimize, and characterize purification processes including Protein A capture, polishing chromatography, viral clearance, filtration, and UF/DF.
Lead process characterization studies toidentifyand justify critical process parameters (CPPs), support control strategy development, and enable process performance qualification (PPQ).
Drive process robustness, scalability, and lifecycle management strategies consistent with commercial manufacturing requirements.
Troubleshoot purification performance issues across development, scale-up, and commercial manufacturing.
Provide technical oversight for scale-up and technology transfer activities to manufacturing sites.
Review and approve development protocols, reports, and technical documentation.
Interpret process development data to support regulatory filings and internal decision-making.
Author and own downstream process development sections of regulatory submissions (e.g., IND, BLA Module 3), including process description, control strategy, and process characterization summaries.
Support responses to regulatory questions andparticipatein health authority interactions as subject matter expert.
Ensure process development documentation supports comparability, validation, and commercial readiness.
Contribute to control strategy development and regulatory justification of CPPs and IPCs.
Partner closely with Upstream Development, Analytical Development, Manufacturing, Quality, Regulatory, and Supply Chain.
Contribute to integrated CMC strategy and program risk assessments.
Support internal and external manufacturing campaigns through data review and real-time problem solving.
Provide mentorship and technical guidance to junior scientists.
Contribute to downstream platform evolution and technical innovation.
Support long-term process optimization and lifecycle management planning.
Help build internal technical capabilities aligned with commercial strategy.
May assumepeopleleadership responsibilities as the organization grows.

Benefits

Avidity offers competitive compensation and benefits, which includes the opportunity forannualbonus 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.

Stand Out From the Crowd

Upload your resume and get instant feedback on how well it matches this job.

Upload and Match Resume