The Laboratory Manager manages the activities of the Analytical Chemistry laboratory, to include supervising laboratory staff, reviewing test results, managing schedules, providing guidance to subordinates; developing and enhancing procedures. Manages all aspects of the laboratory, ensuring compliance to regulatory requirements and providing technical guidance in support of associated operational drug repackaging activities. Manages schedules and tests performed in-house and at contract laboratories. Conducts investigations; performs annual products reviews; tracks key performance indicators; focusing on the core responsibilities of drug stability assurance of the repackaging operation. Critical responsibilities include resolving and troubleshooting complex analytical issues; investigating aberrant/Out Of Specification (OOS) data and the associated reporting; as well as direct management of laboratory staff.
- Managing the timely completion of Stability testing by the Laboratory Chemists/Associates and contract laboratories. Comprehensively and critically reviews test results; identifying tends and managing trends accordingly.
- Optimize laboratory resources while minimizing cost, maintaining regulatory compliance and quality standards. Supports the forecasting of in-house and contract Laboratory needs with respect to budget, equipment, and personnel.
- Ensure regulatory compliance in all laboratory areas including but not limited to performing detailed investigations of aberrant data; performing stability trending to support Annual Stability Reviews for all products; auditing of vendors and contract laboratories; maintaining the data integrity program; writing and/or updating policies and procedures; and ensuring that laboratory equipment is qualified and calibrated.
- Thorough understanding of how results obtained by the Laboratory impact all areas of the business unit and an ability to clearly explain processes, procedures, and finding to regulatory agencies, auditors, and cross functional groups within McKesson.
- Communicating effectively and timely regarding laboratory issues, staffing concerns, and test results that may adversely impact business goals. Escalating promptly to direct supervisor.
- Supervising, managing, training, and developing a staff of technical analytical professionals that may include analytical chemists, microbiologist, and technicians.
- 7-10 years relevant experience in an Analytical/Stability laboratory
- Must have 5 years prior laboratory supervisory and/or laboratory managerial experience
- Regulatory inspection and interaction experience required
- In-depth direct experience with Stability testing, troubleshooting analytical issues, and investigating any laboratory variances.
- Knowledge of FDA regulations and guidance as related to all aspects of a GMP laboratory
- In-depth knowledge of equipment and scientific theory regarding laboratory testing including HPLC, Dissolution, Karl Fischer, etc.
- History of supporting responses to questions from FDA inspectors including Out-of-Specification investigations
- Proficient in mathematics, investigations, and problem solving
- Strong leadership qualities, interpersonal and team-building skills
- Ability to work independently and collaboratively on multidisciplinary teams
- Excellent verbal and written communication skills
- Microsoft Office suite
- Empower experience (preferred)
- LIMS experience (preferred)
- 4 year college degree in Chemistry or science based analytical testing
- General office and Analytical laboratory typical, 50% each
- Physical Requirements (Lifting, standing, etc.) – Usual laboratory physical requirements that include some minor lifting and standing
- Approximately 15% travel may be required