Scientist, Analytical Development/CMC

CMCHybrid Remote, San Diego, California United States


Description

Job Title:

Scientist, Analytical Development/CMC

Location:

Hybrid - San Diego

Position type:

FLSA:

Full time

Exempt

Department:

CMC


Strive to Bring a Profound Difference to our Patients

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 Twitter.

The Opportunity

We seek a Scientist who is experienced and committed to developing AOC analytical methods to support our research and clinical programs to join the Analytics group. The position will report to Scientist II, Analytical Development, and be a part of Avidity's growing CMC/Technical Operations team.

What You Will Contribute

  • Subject matter expert for analytical separation techniques, including SAX, CEX, icIEF, SEC, CE-SDS, and HIC.
  • Independently develops and qualifies analytical methods to support AOC release and stability testing.
  • Works 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.
  • Implements novel analytical techniques to overcome analytical challenges in the characterization of AOCs.
  • Documents experiments in electronic notebooks and writes technical reports summarizing findings.
  • Authors or reviews relevant regulatory submissions.
  • Provide updates and present 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)
  • Other Duties as assigned

What We Seek

  • Minimum BS/MS with 8+ years of experience or PhD with 0-3 years of experience.
  • Deep knowledge of antibody and/or oligonucleotide analytical separation techniques.
  • Understanding of method qualification/validation and transfer to QC. Experience in GMP or QC laboratory a plus.
  • Previous experience as an analytical lead for CMC teams and interacting with CMO/CROs.
  • 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.

 

What We Will Provide to You:

  • The base salary range for this role is $98,000 - $120,000. The final compensation will be commensurate with relevant experience, skillset, internal equity, and market factors.
  • Avidity offers competitive compensation and benefits, including the opportunity for annual and spot bonuses, stock options, RSUs, and a 401(k) with an employer match. In addition, the comprehensive wellness program includes medical, dental, vision, and LTD coverage and four weeks of time off.
  • A commitment to learning and development, including a variety of internal programming developed by and for Avidity employees, opportunities for job-specific training offered by industry, and an education reimbursement program

 

LI-Hybrid

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