Associate Director, Quality Control
17 hours ago
Avidity NanoMedicines is seeking an experienced Associate Director, Quality Control to lead all Quality Control aspects for GMP Operations in all phases of product development. This role will be responsible for ensuring the quality and compliance of our products, and will work closely with cross-functional teams to achieve this goal.
Key Responsibilities:- Establish and drive strategy to ensure compliance with phase-appropriate 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.
- 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.
- BS or MS in Chemistry, Biochemistry, Microbiology, Biology, or other related field.
- 6+ years of related experience within the biopharmaceutical industry in QC management.
- Working knowledge of antibody, antibody drug conjugates, oligonucleotides, and protein analytical methods.
- 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.
- 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.
- Competitive compensation and benefits package.
- Opportunity for annual and spot bonuses, stock options, and RSUs.
- 401(k) with an employer match.
- Comprehensive wellness program.
- Commitment to learning and development.
- Education reimbursement program.
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