PK Processing Lab Manager

Thermo Fisher Scientific • Austin, TX

4d • Onsite

About The Position

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.

Requirements

• Bachelor's 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
• Knowledge of personnel and fiscal management
• Knowledge of preparation of SOP's, 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

Responsibilities

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager