Description
Primary Functions:- Provides group leadership for the stability work group and support staff
- Works with project leaders and clients to develop and execute stability protocols and programs; provides oversight for stability study initiation and scheduling
- Coordinates testing with internal and external laboratories
- Works closely with laboratory management, project leaders, and QA regarding work schedules and assignments to ensure timeliness of deliverables; makes presentations to project teams for stability updates
- Provides oversight for the routine monitoring, calibration, installation, and maintenance of stability facilities and equipment to meet CGMP requirements
- Analyzes data, identifies trends, and prepares quality reports that support the drug development and commercialization process
- Ensures quality and timely review of documentation generated in the stability group
Job Requirements:
- Strong background in pharmaceutical stability programs, ICH and FDA requirements for same, and a working knowledge in regulatory affairs for drug applications
- Working knowledge and application of fundamental statistics associated with stability data analysis (descriptive statistics, regression analysis, etc.)
- Demonstrated ability to lead a group to meet established goals
- Working knowledge and application of program/project management
- Ability to exercise independent intellectual judgment based on their specialized field; ability to plan and schedule activities; detail oriented and well organized
- Ability to communicate effectively both orally and in writing
Required Education/Experience/Training:
Minimum: Bachelor's or Master's degree in pharmacy, chemistry, biology, or related scientific field with at least three (3) years experience in pharmaceutical analysis and stability programs
Preferred: Advanced degree in pharmacy, chemistry, biology or related scientific field with three years previous experience in managing a pharmaceutical stability program
To find out more about Real please visit www.realstaffing.com