At Avidity Biosciences, we are passionate about the impact of every employee in bringing potentially life-changing therapeutics to patients in need. Avidity is pioneering a new class of oligonucleotide-based therapies called AOCs designed to overcome the limitations of oligonucleotide therapies to treat a wide range of serious diseases. We utilize our proprietary AOC platform to design, engineer, and develop transformative therapeutics that combine the tissue selectivity of monoclonal antibodies (mAbs) and the precision of oligonucleotide-based therapies to access previously undruggable tissue and cell types and more effectively target underlying genetic drivers of diseases. If you are a committed, solution-oriented thinker, come make a difference with us.
We are seeking a Scientist to join the Analytics group who is experienced and committed to developing oligonucleotide analytical methods to support our research and clinical programs. This individual will work across departments and must be able to communicate among them. This position will report to the Associate Director, Analytics and Formulations and be a part of Avidity's growing CMC/Technical Operations team.
Essential Duties and Responsibilities
- Strong knowledge of nucleic acids chemistry and oligonucleotide analytical separation techniques. Including IP-RP-UPLC, SEC, AEX, CE-SDS, and HILIC.
- Experience with mass spectrometry techniques to characterize oligonucleotides (Orbitrap, QQQ, Single Quad).
- Independently develops and qualifies analytical methods (IP-RP-UPLC denaturing, non-denaturing, sequencing, identity, residual solvent, and assay content) to support oligonucleotide release and stability testing.
- Works closely with external CROs to advance method development, qualification, transfer, and validation for Avidity programs.
- Provides a detailed review of protocols, reports, and raw data for analytical method qualification/validation, release testing, and reference materials qualification.
- Implements novel analytical techniques to overcome analytical challenges in the characterization of oligonucleotides.
- Documents experiments in electronic notebooks and writes technical reports summarizing findings.
- Authors or reviews relevant regulatory submissions
- Provides updates and presents data proactively and regularly in group and CMC meetings.
- Ensures adherence to applicable regulations, including FDA, EMA, ICH, GMP, and internal Avidity policies.
- Provides leadership and mentorship to laboratory research associates.
- Contributes to the company's core values (agile, visionary, integrated, and diverse).
- Minimum PhD in chemistry, biology, biochemistry, pharmaceutical sciences, with 1-3 years of pharmaceutical industry experience or BS/MS degree with 8-10 years of industry experience or equivalent.
- Deep knowledge of oligonucleotide analytical separation techniques.
- Understanding of method qualification/validation and transfer to QC. Experience in GMP or QC laboratory a plus.
- Proven track record of effective collaboration with external quality control and contract manufacturing organizations.
- Proven ability to thrive and enable success in a cross-functional and collaborative environment.
- Excellent communication and interpersonal skills and the ability to facilitate constructive, expedient problem-solving.
- Ability to multi-task, manage conflict, and work in a fast-paced environment.
Salary range - $106,506 - $130,000 salary commensurate with experience