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Stability Program Manager
2 months ago
Position Summary:
Bell International Laboratories is seeking a highly skilled Program Manager for the Commercial and Research and Development stability programs. The ideal candidate will be responsible for the execution of the stability program, which includes initiating stability protocols, scheduling stability inventories, coordinating stability pulls, ensuring timely testing of products, compiling comprehensive stability reports, and analyzing data trends over the product shelf-life. This role requires close collaboration with various departments and the ability to manage multiple projects while prioritizing Safety, Quality, and Customer Service.
Responsibilities
- Regulatory Compliance: Maintain a deep understanding of ICH Stability, cGMPs, and FDA Guidance to effectively manage the stability program.
- Protocol Development: Author and implement stability protocols prior to the initiation of stability studies.
- Cross-Department Collaboration: Work closely with QC, R&D, QA, and Regulatory to identify products, establish testing criteria, and determine the appropriate type of stability studies required.
- Sample Management: Initiate and track stability sample requests according to company procedures, ensuring accurate documentation and inventory schedules. Ensure samples are stored and removed from stability chambers in a timely manner according to the schedule.
- Stability Scheduling: Create monthly stability pull lists based on the type of stability study and ensure timely execution.
- Data Integrity and Review: Thoroughly review, track, and trend stability data to ensure compliance with company procedures and regulatory standards.
- Report Compilation: Compile data into detailed stability reports, identifying and trending data based on the requirements in the stability protocols.
- Issue Identification: Identify, investigate and report any out-of-trend or out-of-specification data to laboratory management.
Required Skills/Abilities
Industry Knowledge: Extensive experience in a cGMP laboratory environment.
Stability Program Management: Proven track record in managing stability programs effectively.
Regulatory Acumen: In-depth understanding of ICH and FDA stability guidance.
Attention to Detail: Exceptional documentation skills with meticulous attention to detail.
Problem-Solving: Strong critical thinking and troubleshooting abilities.
Team Collaboration: Highly motivated, collaborative team player with excellent communication skills.
Adaptability: Ability to organize, prioritize, and adapt to changing business needs and priorities.
Technical Proficiency: Proficient in Microsoft Office and statistical analysis software, capable of multitasking with minimal supervision.
RequiredEducation and Experience
- Academic Background: Bachelor’s degree in chemistry or a related field.
- Professional Experience: Minimum of 4-6 years of experience in a cGMP laboratory environment, preferably within the pharmaceutical manufacturing.
