Laboratory Manager

Job Title:

Bioanalytical Laboratory Manager

Location:

Somerset, New Jersey, USA

Position Summary:

Reporting to site leadership, the Bioanalytical Laboratory Manager is responsible for the operational and quality success of the Somerset bioanalytical laboratory. This role ensures the delivery of high-quality, compliant, and efficient laboratory operations through hands-on management of staff, facilities, and instrumentation-including LC-MS/MS and immunochemistry platforms. The Lab Manager will lead day-to-day lab activities, support ongoing and future platform expansions (e.g., qPCR, flow cytometry), and maintain a culture of excellence as we ramp up new studies and capabilities.

Key Responsibilities:

+ Oversee daily operations of the bioanalytical lab, including scheduling, resource management, instrument maintenance, and the coordination of scientific staff for small molecule and large molecule studies.

+ Supervise and mentor laboratory team members; manage performance, training, and development of analysts, scientists, and technicians.

+ Ensure studies are executed to the highest scientific, quality, and regulatory standards (GLP, GCP), aligning with SOPs and validation protocols.

+ Coordinate with QA for audits, method validation, and process improvement; partner with QA Officers on execution of mock studies, investigation of process deviations, CAPAs, and change management.

+ Implement, validate, and optimize eQMS/LIMS; champion the use of digital systems for efficient sample and data management.

+ Maintain readiness for regulatory and client audits; support inspection preparation and response.

+ Oversee sample and inventory management, chain-of-custody, and storage logistics in compliance with study protocols and regulatory expectations.

+ Proactively identify process bottlenecks and drive continuous improvement in laboratory workflows, safety, and operational excellence.

+ Support platform and space expansions (e.g., bringing qPCR and flow cytometry online); participate in hiring and onboarding of new scientific staff to meet demand.

+ Interface with Project Managers, Analytical Scientists, QA, IT, and external partners to support timely, accurate project delivery.

+ Promote a positive, collaborative work environment in alignment with Ardena values and North American business goals.

Qualifications:

+ Bachelor's or Master's degree (or higher) in Chemistry, Biochemistry, Biology, Pharmaceutical Sciences, or related discipline.

+ Minimum 5 years' experience in a regulated bioanalytical laboratory (GLP/GCP/GMP), with clear progression in technical and/or leadership roles.

+ Proficiency with bioanalytical platforms (especially LC-MS/MS, immunochemistry); experience managing lab teams supporting preclinical and clinical studies.

+ Familiarity with the implementation and use of eQMS/LIMS systems.

+ Strong working knowledge of regulatory requirements (FDA, EMA, ICH M10) and best laboratory practices.

+ Demonstrated leadership, team management, and interpersonal skills.

+ Excellent organizational, problem-solving, and communication abilities.

+ Experience in analytical platform expansion (e.g., immunochemistry, qPCR, flow cytometry) is desirable.

As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account.

In addition, employees are entitled to earn paid sick leave under the applicable state or local plan.  ()  for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.

Why Kelly ®  Science & Clinical?

Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the world's…