Provides leadership to the Metrology and Lab Support functions(Stability Program) within the combined Cincinnati Site laboratories. Establishes and maintains an instrument calibration program, identifies and recommends new technologies and leads the development of stability and laboratory support infrastructure. Ensures that all activities in the group are performed according to a set schedule and in accordance with Standard Operating Procedures (SOPs), current Good Manufacturing Practices (GMP) and corporate quality standards.
Provides leadership to assigned staff by performing the following: leading organziational change; developing and empowering staff; cultivating relationships; putting staff in a position to succeed; meeting their personal career goals while also achieving organizational goals; building effective teams that apply their diverse skills and perspectives to achieve common goals; driving engagement and creating a climate where staff are motivated to do their best. Manages and coordinates IQ/OQ/PQ (Installation Qualification/ Operation Qualification/ Performance Qualification) and preventative maintenance (PM) activities on all new and existing equipment. Manages and coordinates logisitics of the site stabilty programs for Development and Analytical Operations. Designs, develops and periodically review/update SOPs related to instrument calibration. Troubleshoots and ensures that malfunctioning equipment is repaired in a timely manner. Reviews and makes recommendations for additional resources or improvements in the delivery of lab support services. Keeps up to date with advances in analytical, pharmaceutical and regulatory developments, in particular those related to analytical instrumentation, and makes recommendations for any new types of analytical testing equipment that should be considered for use in AD. Performs other duties as assigned.
Receives assignments in the form of objectives and determines how to use resources to meet schedules and goals.
Manages the coordination of the activities of a section or department with responsibility for results.
Bachelor’s degree in Science, Pharmaceutical Analysis, Analytical Instrumentation or related field.
Six to eight years of instrumentation validation experience in the pharmaceutical industry. Previous supervisory and training experience preferred.
Equivalent combinations of education, training, and relevant work experience may be considered.
Good knowledge of Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), International Conference on Harmonization (ICH) and United States Food and Drug Administration (FDA) compliance knowledge. Thorough knowledge and understanding of analytical instrumental technologies. Excellent interpersonal and communication skills (both oral and written).
Strong proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint). Well organized and detail oriented. Ability to work well independently and in a team environment.