Laboratory Manager, Lab Metrology & Support Functions
About the Job
When you’re part of the team at Thermo Fisher Scientific, you’ll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you’ll be supported in achieving your career goals.
Location/Division Specific Information
How will you make an impact?
Provides leadership to the Pharmaceutical Laboratory Equipment Metrology and Lab Support functions (Stability and Sample management, Swabs and PMQA) within the combined Cincinnati Site laboratories. Establishes and maintains an instrument calibration program, swab analysis program, sampling and inspection program 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.
What will you do?
- Provides leadership to assigned staff by performing the following: leading organizational 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 logistics of the site stability programs for Development and Analytical Operations.
- Manages the PMQA and Swabs teams and develops and periodically review/update SOPs related to instrument calibration and associated job functions.
- 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.
How will you get here?
- 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.
Knowledge, Skills, Abilities:
- 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.
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $25 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them. Our global team of more than 75,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. For more information, please visit www.thermofisher.com.
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.