About the position
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. This individual will provide input to cross-functional teams and ensure effective communication with colleagues and external partners. Excellent verbal and written communication skills are essential for success in this position including extensive experience successfully managing multiple CTOs and CMOs. This position will report to the Sr. Manager, QC Stability and be a part of Avidity's CMC / Technical Operations team.
Responsibilities
- 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 stability 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 AOCs.
- Assess, analyze, and trend stability data.
- Author shelf-life justification reports.
- Support oversight of QC activities at CMOs including SOW review, data quality, and adherence to timelines.
- Communicate data both verbally at group meetings, CMC teams, and through written documents and reports.
- Assist in the preparation of CMC regulatory submissions.
- Write and revise standard operating procedures.
- Work with project leads to address delays and escalate when necessary.
- Support other QC activities and projects as needed.
- This position may require travel (approximately 10%).
Requirements
- 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, with a focus on QC Stability
- 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 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.
Benefits
- The base salary range for this role is $142,500 - $157,500.
- 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.
- 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.
