Manager, Quality Control

Avidity Biosciences Inc

13h • Hybrid

About The Position

At Avidity Biosciences, A Novartis Company, we are passionate about the impact of every employee in bringing potentially life-changing therapeutics to patients in need. Avidity is pioneering a new class of oligonucleotide-based therapies called AOCs designed to overcome the current limitations of oligonucleotide therapies to treat a wide range of serious diseases. We utilize our proprietary AOC platform to design, engineer and develop transformative therapeutics that combine the tissue selectivity of monoclonal antibodies (mAbs) and the precision of oligonucleotide-based therapies to access previously undruggable tissue and cell types and more effectively target underlying genetic drivers of diseases. If you are a committed, solution-oriented thinker, come make a difference with us.

The Manager, Quality Control will support Quality Control aspects for GMP Operations in all phases of product development. The primary function of this position will be accountability for external QC analytical and microbiology activities to support the release and stability testing of Avidity products produced and tested at CMO/CTOs. The candidate will be Avidity’s primary analytical and microbiological point of contact for managing selective CMO/CTOs which manufacture and test Avidity’s materials (intermediates, drug substances and drug products). Excellent verbal and written communication skills are essential for success in this position including extensive experience successfully managing multiple CTOs and CMOs. This role will support the development of QC systems and procedures and continue building relationships with our CMO/CTO network. The candidate will interface with Quality Assurance, Supply Chain, Manufacturing, Analytical Development, Regulatory and other cross-functional teams as required. This position will report to Associate Director of Quality Control and be a part of Avidity’s growing CMC/Technical Operations team.

Requirements

• Extensive QC experience in a cGMP biologics regulated manufacturing environment is required.
• BS or MS in a Chemistry, Biochemistry, Microbiology, Biology, or other related field
• 5+ years of related experience within the biopharmaceutical industry in QC management.
• 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 with limited direction 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
• Sound understanding and demonstrated application of statistical methods/tools
• Excellent interpersonal skills, outstanding organizational skills, and excellent written and oral communication skills.

Nice To Haves

• Working knowledge of antibody, antibody drug conjugates, oligonucleotides and protein analytical methods is strongly preferred.

Responsibilities

• Provide oversight of QC activities at external CMOs/CTOs.
• Be the point of contact for selective CMOs/CTOs from initiation of vendor contact through release and stability testing.
• Support 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.
• Support QC team with development of system and tools for ensuring supply of critical reagents, reference standards, and controls at CMOs/CTOs.
• Work with QC team to support development of systems/tools, KPIs, and databases 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.
• 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 adhering with appropriate GMP compliance as it relates to testing, data integrity and deviation/investigation content.
• Communicate data both verbally at group meetings, CMC teams, and through written documents and reports.
• Author, review, and/or approve product specifications, 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.

Benefits

• The base salary range for this role is $137,100 - $151,500.
• opportunity for annual and spot bonuses
• 401(k) with an employer match
• medical, dental, vision, and LTD coverage
• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Number of Employees: 101-250 employees