Reporting to the Associate Director, Quality Control - Stability and Trending, the Stability Coordinator manages the GMP stability programs, supporting trending of methods, reference standard, and stability data to improve process and product understanding, and to support problem solving and decision making. The successful candidate will support clients across Kiniksa, including Analytical Development, Quality Control, Manufacturing, CMC, Validation, and Quality Systems.
This role is based in our Lexington, MA office and requires employees to be onsite five days per week.
Responsibilities (including, but not limited to):
- Oversee systems supporting GMP stability programs including tracking and trending of stability data, generation of protocols and reports, and driving timely completion of quality records
- Maintain stability testing records and results within the stability software to assure traceability and availability of records
- Collaborate with contract laboratories to ensure timely completion of testing and delivery of QC deliverables for stability programs
- Review and approve laboratory data and results, ensuring their traceability and integrity
- Generate and present stability metrics to support annual reports, regulatory filings, and internal decision-making
- Perform routine trending of stability data to support shelf-life of GMP products
- Evaluate product stability data to establish and extend product shelf-life
- Coordinate shipping and sample management of routine and non-routine testing activities
- Drive process improvements and ensure inspection readiness (ISO, GMP alignment) for area of responsibility
- Create and improve procedures related to GMP stability programs
- Support batch certificate and Certificates of Analyses generation and additional tasks as required
- Participate in the authoring and review of QC protocols and stability reports
Standout Skills for Impact:
- Proven ability to manage projects and work with cross-functional teams comprised of internal and/or external contacts, including CTLs
- Proactive, with a strong desire to engage with clients, and act with urgency and passion
- Strong ownership mindset with the ability to drive timelines and resolve issues in collaboration with internal teams and external partners
- Ability to translate stability data and trends into clear insights that support decision-making, regulatory strategy, and product lifecycle management
Qualifications and Experience:
- BS in a scientific area with 3-5 years of experience in Quality Control in a GMP setting
- Working knowledge of statistical tools, methodologies, and related software, including experience with JMP as a plus
- Experience working with contract testing laboratories or external vendors in a regulated environment
- Ability to review analytical data for completeness, accuracy, traceability, and compliance with applicable procedures
- Effective verbal and written communication skills
- Proven ability to work with a high level of integrity, accuracy, and attention to detail
- Familiarity with ICH stability guidelines and expectations for pharmaceutical products
- Knowledge of quality systems and domestic and international regulatory requirements