Manager, Quality Control Stability - Remote

Overview

The Manager, Quality Control Stability 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 substance and drug product.

In Short

• 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.
• Provide technical review for stability data from various assays across multiple product types.
• Assess, analyze, and trend stability data.
• Author shelf-life justification reports.
• Support oversight of QC activities at CMOs.
• Communicate data verbally and through written documents and reports.
• Assist in the preparation of CMC regulatory submissions.
• Write and revise standard operating procedures.
• Support other QC activities and projects as needed.

Requirements

• BS or MS in a Chemistry, Biochemistry, Microbiology, Biology, or related field.
• 5+ 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.
• Highly collaborative team player.
• A passion for addressing the critical unmet medical needs of patients.
• Self-directed individual who can work with limited direction.
• Ability to organize data and identify gaps.
• Knowledge of Good Manufacturing Practices and Good Laboratory Practices.
• Experience managing CMO relationships and projects.

Benefits

• The base salary range for this role is $142,500 - $157,500.
• Avidity offers competitive compensation and benefits including annual bonuses, stock options, and a 401(k) with employer match.
• Comprehensive wellness program including medical, dental, vision, and four weeks of time off.
• Commitment to learning and development with job-specific training and education reimbursement.