Scientist II, Analytical Development (Oligonucleotide)
BioSpace · San Diego, CA · Today
On-siteAnalyst$120k–$222k/yrFull-time
About the role
Avidity Biosciences is revolutionizing the field of RNA with its proprietary AOCs, designed to deliver a new class of RNA therapeutics. This role contributes to the development and running of oligonucleotide methods to support Avidity's AOC research and clinical programs.
Responsibilities
- Develop and qualify analytical methods for oligonucleotide release and stability testing.
- Work closely with external CROs to advance method development, qualification, transfer, and validation for Avidity programs.
- Provide a detailed review of protocols, reports, and raw data for analytical method qualification/validation, release testing, and reference materials qualification.
- Implement novel analytical techniques to overcome analytical challenges in the characterization of oligonucleotides.
- Document experiments in electronic notebooks and write technical reports summarizing findings.
- Authors or reviews relevant regulatory submissions.
- Provide updates and present data proactively and regularly in group and CMC meetings.
- Ensure adherence to applicable regulations, including FDA, EMA, ICH, GMP, and internal Avidity policies.
- Contribute to the company's core values (agile, visionary, integrated, and diverse).
Requirements
- 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.
- 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.
Qualifications
- Strong knowledge of nucleic acids chemistry and oligonucleotide analytical separation techniques.
- Experience with mass spectrometry techniques to characterize oligonucleotides (Orbitrap, QQQ, Single Quad).
Skills
- Independent problem solver with strong attention to detail.
- Effective communicator and collaborator.
- Ability to work in a fast-paced, dynamic environment.
Benefits
To learn more about Avidity Biosciences' benefits, visit our careers page.