Senior Scientist, Analytical Development at Avidity Biosciences

 Job Title:Senior Scientist, Analytical DevelopmentLocation:San Diego, CA / HybridPosition type:FLSA:Full time ExemptDepartment:TD&OStrive to Bring a Profound Difference to our PatientsAt 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 OpportunityWe are seeking an experienced and highly energetic Senior Scientist / Scientist who is interested in helping Avidity grow into a late-stage clinical and commercial manufacturing company. The person should have prior hands-on analytical knowledge and will work internally and externally as an Analytical Development team lead. This position will report to the Associate Director of Analytical Development and be part of Avidity's growing CMC/Technical Operations team.What You Will Contribute

• Subject matter expert for Biologic and Oligonucleotide analytical separation techniques including Mass Spectrometry, SAX, CEX, icIEF, SEC, CE-SDS, HIC, and IP-RP-UPLC.
• Works closely with external CROs to advance method development, qualification, transfer, and validation for Avidity programs. 
• Lead characterization studies, setting scientifically justifiable comparability strategies and control strategies.
• Communicate program updates at CMC/Technical Operations meetings.
• Author, review, and/or approve documents such as validation protocols/reports, test methods, justification of specifications, stability protocols, comparability protocols, and relevant sections of regulatory filings (IND, IMPD, BLA, etc.).
• 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). 

What We Seek

• Minimum PhD in chemistry, biology, biochemistry, or pharmaceutical sciences, with 6+ years of pharmaceutical industry experience or BS/MS degree with 15+ years of industry experience. 
• Previous experience as an analytical lead for CMC teams and interacting with CMO/CROs.
• Deep knowledge of antibody and/or oligonucleotide analytical separation techniques. 
• Significant and established experience in 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. 
• Experience with impurity identification and mass spectrometry techniques to characterize AOCs. 
• 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 $127,000 - $157,000. 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, and RSUs, 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.
• 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.