Description
Job Title:
QC Stability Specialist
Location:
San Diego, CA
Position type:
FLSA:
Full time
Exempt
Department:
CMC / Technical Operations
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
The QC Stability Specialist position will lead QC activities associated with the day-to-day coordination and execution of the stability program at Avidity. This position will oversee stability data generated at CMOs/CROs relating to the GMP testing of Avidity's products, including drug substance intermediates, drug substances, and drug products. This individual will provide input to cross-functional teams and ensure effective communication with colleagues and external partners. This position will report to the Sr. Manager, QC Stability, and be a part of Avidity's CMC / Technical Operations team.
What You Will Contribute

• Manage and oversee the stability program and QC testing in accordance with Avidity procedures and regulatory guidelines.

• Support cGMP operations and technical review of both internal and external (CMO) records, including test records/reports, protocols, change controls, deviations, and OOS.
• Provide technical review for stability data from various assays across multiple product types, including mAb, oligonucleotide, and DS/DP AOC (Antibody oligonucleotide conjugate).
• Assess, analyze, and trend stability data.
• Author shelf-life extension reports.
• Support oversight of QC activities at CMOs, including SOW review, accountability for timelines and data quality, and communication of updates.
• Assist in the preparation of CMC regulatory submissions.

• Write and revise standard operating procedures.
• Support other QC activities and projects as needed.
• This position may require travel (approximately 10%).
• Other activities as required.

What We Seek
The ideal candidate for this position will have extensive experience with QC functions associated with GMP production and testing of biologics and small molecules in both clinical and commercial settings. The candidate will have a strong technical background and a proven track record in Quality Control with methods related to biologics, small molecule, and AOC/ADC modalities.

• A Bachelor's degree in Biological Sciences, Bioengineering, Chemistry, or related field
• 6 years of experience in the biotechnology or pharmaceutical industry with a focus on QC stability
• Experience managing external CMO/CTO
• Knowledge of a variety of analytical techniques i.e. U/HPLC (SEC, AEX, RP-HPLC), CE-SDS, icIEF, ELISA, GC, UV, sub-visible particle analysis (MFI, HIAC), CCIT, pH, Osmolality, KF
• Strong organizational and communication skills, detail oriented, and able to manage multiple projects and timelines
• Experience with QC regulatory/pharmacopeia requirements
• Background/familiarity in method transfer, comparability, development, qualification, and validation a plus

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 such factors as relevant experience, skillset, internal equity and market factors.
• Avidity offers competitive compensation and benefits which includes 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 which includes a variety of programming internally developed by and for Avidity employees, opportunities for job-specific training offered by industry, and an education reimbursement program.

Avidity Biosciences
10578 Science Center Dr. Suite 125
San Diego, CA
92121
O: 858-401-7900
F: 858-401-7901