Associate Director, Quality Control

Avidity Biosciences Inc

10h•Hybrid

About The Position

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.

Requirements

BS or MS in Chemistry, Biochemistry, Microbiology, Biology, or other related field.
8+ years of related experience within the biopharmaceutical industry in QC management.
Working knowledge of antibody, antibody drug conjugates, oligonucleotides, and protein analytical methods is strongly preferred.
Demonstrated knowledge of cGMP/ICH/FDA/EU/PMDA regulations.
Demonstrated knowledge of USP, EP, and JP monographs.
Highly collaborative team player who fosters open communication and facilitates mutual understanding and cooperation between all stakeholders.
A passion for addressing the critical unmet medical needs of patients.
Self-directed individual who is able to work in a fast-paced, goal-oriented environment.
Ability to organize data and identify gaps.
Knowledge of Good Manufacturing Practices and Good Laboratory Practices.
Experience of managing CMO relationships and projects.
Experience with authoring IND/IMPD and BLA submissions.
Sound understanding and demonstrated application of statistical methods/tools.
Capable of strategic thinking that drives prioritization in the midst of a dynamic environment with multiple priorities.
Excellent interpersonal skills, written and oral communication skills, and outstanding organizational skills.

Nice To Haves

Extensive QC management experience in a cGMP biologics-regulated manufacturing environment.
Strong technical background and proven track record in Quality Control related to biologics, oligonucleotide, small molecules, and AOC (Antibody Oligonucleotide Conjugate)/ADC (Antibody Drug Conjugate) modalities.

Responsibilities

Establish and drive strategy to ensure we are ready and compliant with phase-appropriate – early to late-stage and commercial– Quality Control requirements at Avidity’s CMOs/CTOs.
Provide oversight of all QC activities at external CMOs/CTOs.
Be the point of contact for all CMOs/CTOs from initiation of vendor contact through release and stability testing.
Lead analytical technology transfers to CTOs and CMOs and interface with Avidity’s analytical and process development teams to facilitate technology transfers.
Enable testing activities within Avidity’s CMO and CTO network to support release and stability of intermediates, drug substance, and drug product.
Develop system and tools for ensuring supply of critical reagents, reference standards, and controls at CMOs/CTOs. Track inventory and burn rate. Where appropriate, enable CMOs/CTOs to qualify critical reagents, reference standards, and controls and maintain and report inventory at regular intervals.
Develop systems/tools and database to track and review release and control data to ensure ease of data reporting and ensure appropriate analytical performance.
Proactively identify and troubleshoot issues to prevent missed timelines and identify opportunities for improvement in QC operations at CMOs/CTOs.
Drive from End-to-End deviation/OOS investigations as it relates to analytical and microbiological QC testing and implement CAPAs and change controls.
Develop and track KPIs for external QC and CMOs/CTOs. Hold CMOs/CTOs accountable to deliver on contractual requirements and data delivery for release and stability testing.
Work with QA to ensure CMOs and CTOs are audit ready, based on CMC milestones and program requirements.
Communicate data both verbally at group meetings, CMC teams, and through written documents and reports.
Author, review, and/or approve SOPs, policies, risk assessments, and technical reports.
Support of cGMP operations, including technical review of change control documentation and reports, deviations, OOSs and other manufacturing and laboratory investigations.
Work with project leads to address delays and escalate when necessary.
Assist in the preparation of CMC regulatory submissions.
Support other QC activities and projects as needed.