Coordinator/ Sr. Coordinator, QC Stability

Job Summary:   

The Senior Coordinator, QC Stability will lead activities associated for the day-to-day management of the Avidity’s stability program.  This individual will help oversee Avidity’s testing strategy per ICH guidelines and ensure adherence to FDA/EMA regulations, and be responsible for data entry and tracking, statistical analysis, and data trending.  This individual will provide operational and strategic input to cross-functional teams and ensure effective communication with colleagues and business partners.  This position will also support management of the Company’s designated Contract Testing Organizations (CTOs).  This position will report to the Manager, CMC Stability Programs and be a part of Avidity’s growing CMC / Technical Operations team.

Essential Duties and Responsibilities: 

• Maintain a GMP compliant stability program, including vendor oversite for protocol writing, stability planning and set-up, stability report writing, and stability data trending.
• Support oversight of QC activities at CTOs, including the review of test records/forms, final reports, Standard Operating Procedures (SOPs) and COAs
• Review QC stability testing data to ensure agreed upon cycle times are met, associated records are evaluated and data are accurate, valid, and complete 
• Generate reports and coordinate review and approval of shelf life, retest dates and expiry dating of GMP materials
• Write and revise standard operating procedures as needed.
• Prepare specifications and Certificates of Analysis (COA) for QA review
• Establish and execute stability programs for intermediates, cell banks, drug substances, and drug products
• Assist in the preparation of CMC regulatory submissions
• Other activities as required

Qualifications:

The ideal candidate for this position will have demonstrated in-depth experience of establishing and managing QC functions associated with the GMP production and testing of biologics in both clinical and commercial settings.

• A Bachelor’s degree in Biological Sciences, Bioengineering, or Chemistry
• 4+ years of experience in the biotechnology or pharmaceutical industry with a primary focus on QC stability, experience with biologic products preferred
• Knowledge of a variety of analytical techniques (eg: SEC, AEX, RP-HPLC, CE-SDS, icIEF, ELISA, GC, UV, sub-visible particle analysis, CCIT)
• Skills and knowledge of implementing and managing a compliant stability program.
• Strong organizational skills, detail oriented, and able to manage multiple projects and timelines
• In-depth experience of QC stability testing and regulatory/pharmacopeia requirements
• Knowledge of Good Manufacturing Practices and Good Laboratory Practices.
• Strong communication and presentation skills required.
• Experience of managing CMO/CTO relationships and projects
• Sound understanding and demonstrated application of statistical methods/tools preferred
• Excellent interpersonal skills, outstanding organizational skills, and excellent written and oral communication skills
• Salary range - $70,000 - $132,000 Salary commensurate with experience