Clinical Lab Manager - Chemistry/Special Chemistry (ASCP)

Work Schedule

Environmental Conditions

Job Description

At Thermo Fisher Scientific youll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life enabling our customers to make the world healthier cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research development and delivery of lifechanging therapies. With clinical trials conducted in 100 countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio our work spans laboratory digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on now and in the future.

Our PPD Laboratory Services team has a direct impact on improving patient health through the expertise of scientists industry thoughtleaders and therapeutic experts. As the world leader in serving science our laboratory professionals bring their commitment to accuracy and quality to deliver groundbreaking innovations.

Location/Division Specific Information:

• PPD clinical research business of Thermo Fisher Scientific

• Global Central Lab in Highland Heights Kentucky

• Chemistry/Special Chemistry

Discover Impactful Work

The Clinical Lab Manager is responsible for managing all operational aspects within the laboratory. Manages staff and relationships of laboratory partners including third party laboratories (3PL) and lab alliances. Plans and implements improvements in systems processes and procedures for the unit to increase efficiency productivity and quality in the laboratory. Hosts and facilitates regulatory inspections audits (internal and external) assists in strategic planning business development and expansion initiatives.

Essential Functions:

• Manages and directs work responsibilities of staff as well as prioritizing tasks and resources.

• Directs staff to meet departmental key process improvements (KPIs) such as quality initiatives and therapeutic area training (TAT).

• Oversees daily operations in the laboratory with respect to troubleshooting instrumentation out of specification/atypical result investigations analytical methods and reports review and approval of protocols data interpretation and evaluation etc.

• Monitors assesses and manages third party lab performance to meet contractual expectations working with objective metrics and satisfaction surveys.

• Works with operations and 3PLs and surfaces and resolves issues and to identify and initiate process improvements.

• Directs and manages the implementation of departmental goals and fiscal policies.

• Assists management in strategic planning capabilities development projections and other financial issues.

• Initiates and implements plans develops and improves areas of the laboratory for greater efficiency productivity and quality.

• Maintains and monitors accreditation and inspection standards keeping the laboratory in compliance with regulatory standards.

• Coordinates inventory monitoring performs all ordering and requisitioning of supplies synchronizing this activity with the other sections.

• Manages staff which may include interviewing and selection job description preparation professional development goal setting performance management coaching and mentoring employee counseling and separations.

• Approves courses of action on salary administration hiring corrective action and terminations.

• Reviews and approves time records expense reports requests for leave and overtime.

Keys to Success

Education

• Bachelors degree or equivalent and relevant formal academic / vocational qualification

Experience

• 5 years of previous experience that provides the knowledge skills and abilities to perform the job.

• 1 year of leadership responsibility

In some cases an equivalency consisting of a combination of appropriate education training and/or directly related experience will be considered sufficient for an individual to meet the requirements of the role.

Knowledge Skills and Abilities

• Previous experience in Chemistry/Special Chemistry strongly preferred

• Familiarity with CAP/CLIA regulations and method development/validation strongly preferred

• ASCP certification preferred (current or past)

• Knowledge of personnel and fiscal management

• Knowledge of preparation of SOPs protocols and other technical documents

• Knowledge of analytical instrumentation

• Proficient with Microsoft Office

• Excellent critical thinking skills to support quality decisionmaking

• Excellent written and verbal communication skills

• Ability to multitask and strong time management skills

• Ability to strategize design and implement effective supply chains and service operations models through innovative combination of people/organization process and technology solutions

• Ability to work in a collaborative team environment

Benefits

Thermo Fisher Scientific offers employment with an innovative forwardthinking organization and outstanding career and development prospects. We offer an exciting company culture that stands for integrity intensity involvement and innovation! We provide comprehensive benefits including an annual incentive plan bonus medical dental vision pharmacy employee assistance program wellness program options and more! Other benefits include:

• 401k with matching contributions life insurance long term and short term disability insurance flexible medical and dependent care spending accounts.

• Worklife balance programs including paid time off for vacation/sick time paid holidays floating holiday.

• Wellness benefits including health and wellness programs fitness facility access or discount health coaching and more.

Work Environment
Thermo Fisher Scientific values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:

• Able to communicate receive and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.

• Able to work upright and stationary and/or standing for typical working hours.

• Able to lift and move objects up to 25 pounds.

• Able to work in nontraditional work environments.

• Able to use and learn standard office equipment and technology with proficiency.

• May have exposure to potentially hazardous elements including infectious agents typically found in healthcare or laboratory environments.

• Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.

Our Mission is to enable our customers to make the world healthier cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100000 colleagues we share a common set of values Integrity Intensity Innovation and Involvement working together to accelerate research solve complex scientific challenges drive technological innovation and support patients in need. #StartYourStory with PPD part of Thermo Fisher Scientific where diverse experiences backgrounds and perspectives are valued.

Apply today!

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.

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