Supervisor, QC - Stability
The QC Supervisor, Stability will oversee daily operations and assist in preparation and implementation of company policies, quality systems, and training programs. The position will perform daily work assignments accurately and in a timely and safe manner. This position will perform complex scientific work, evaluating, selecting and applying standardized scientific procedures and techniques to assignments with clear, specific objectives; assignments require investigation of a number of variables and several complex features. Extensive exercise of judgment is required on details of work and in making preliminary selections and adaptations of alternatives.
• Supervises assigned Stability testing staff members and their daily work activities including: workload, ensuring training, general guidance to direct reports and across functional groups, and serves as resource for technical / administrative problems.
• Hires, trains, motivates, leads, develops and evaluates staff. Takes corrective action as necessary on a timely basis and in accordance with company policy. Ensures compliance with current federal, state and local regulations. Consults with Human Resources Department as appropriate.
• Provides scientific and operational leadership in the areas of cGMP-compliant molecular testing services that include HPLC, Capillary Electrophoresis, iCE, SDS PAGE, and ELISA for stability programs. Supports communication with clients as well as manages timelines to ensure stability reports are issued on time.
• Reviews analyses of activities, costs, operations, and forecast data to determine progress toward stated goals and objectives.
• Identifies and addresses technical and validation gaps in analytical methods and implements improvements in analytical methods per ICH requirements.
• Keeps up to date on new technologies and changes in CMC and other regulatory requirements.
• Documents work according to SOP's and compliance requirements.
• Represents Catalent with clients and prospective clients at on-site and external meetings, as required.
• Identifies, evaluates and executes on process improvements to increase existing capabilities.
• Ensures strong interaction with multiple groups to facilitate appropriate resource allocation and scheduling of signed projects.
• Other duties as assigned.
III. Position Requirements:
• Ph.D. in Chemistry, or related field with at least 2 years of experience
• MS in Chemistry, or related field with at least 3 years of experience
• B.S/B.A. in Chemistry, or related field with at least 7-9 years of experience
• 7+ years of relevant work experience in a current Good Manufacturing Practices (cGMP) environment with progressive responsibilities
• Prior pharmaceutical Quality experience
• Prior cGMP documentation and experience
• Experience mentoring/supervising junior staff regarding laboratory procedures
• Experience writing Standard Operating Procedures and analytical methods
• Experience with Analytical laboratory OOS and atypical investigations (including root cause analysis).
• Troubleshooting complex analytical instrumentation (eg. HPLCs) and various other analytical equipment.
Strongly prefers - QC and experience with stability programs, stability testing, and managed stability protocols