PK Processing Lab Manager

Work Schedule

Environmental Conditions

Job Description

Join Us as а Lab Manager - Make an Impact at the Forefront of Innovation
The Lab Manager oversees all operational aspects within the pharmacokinetic (PK) processing laboratory. This role includes managing staff and relationships of laboratory partners including third party laboratories (3PL) and lab alliances. The manager plans and implements improvements in systems processes and procedures for the unit to increase efficiency productivity and quality in the laboratory. Additionally hosts and facilitates regulatory inspections audits (internal and external) assists in strategic planning business development and expansion initiatives.


What Youll Do:
Manage and direct work responsibilities of staff as well as prioritizing tasks and
resources. Direct staff to meet departmental key process improvements (KPIs)
such as quality initiatives and therapeutic area training (TAT). Oversee 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.
Monitor assess and manage third party lab performance to meet contractual expectations working with objective metrics and satisfaction surveys. Work with operations and 3PLs and surfaces and resolve issues and to identify and initiate process improvements.
Direct and manage the implementation of departmental goals and fiscal policies. Assist management in strategic planning capabilities development projections and other financial issues.
Initiate and implement plans develop and improve areas of the laboratory for greater efficiency productivity and quality. Maintain and monitor accreditation and inspection standards keeping the laboratory in compliance with regulatory standards.
Coordinate inventory monitoring perform all ordering and requisitioning of supplies synchronizing this activity with the other sections.
Manage staff which may include interviewing and selection job description preparation professional development goal setting performance management coaching and mentoring employee counseling and separations. Approve courses of action on salary administration hiring corrective action and terminations. Review and approve time records expense reports requests for leave and overtime.


Education & Experience Requirements:
Bachelors degree or equivalent and relevant formal academic / vocational qualification
Previous experience that provides the knowledge skills and abilities to perform the job (comparable to 5 years).
3 years 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 Abilities:
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 decision-making
Excellent written and verbal communication skills
Ability to multi-task 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.

Working Conditions and Environment:
Work is performed in an office and/or a laboratory and/or a clinical environment with exposure to electrical equipment.
Occasionally drives to site or client locations rarely travels within the United States.
Exposure to biological fluids with potential exposure to infectious organisms. Rare exposure to skin and lung irritants radiation toxic materials and hazardous waste.
Personal protective equipment required such as protective eyewear garments and gloves.
Exposure to fluctuating and/or extreme temperatures on rare occasions.