Laboratory Manager

Reporting to site leadership, the Bioanalysis 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 disciplin Minimum 5 years’ experience in a regulated bioanalytical laboratory (GLP/GCP/GMP), with clear progression in technical and/or leadership role Proficiency with bioanalytical platforms (especially LC-MS/MS, immunochemistry); experience managing lab teams supporting preclinical and clinical studie Familiarity with the implementation and use of eQMS/LIMS system Strong working knowledge of regulatory requirements (FDA, EMA, ICH M10) and best laboratory practice Demonstrated leadership, team management, and interpersonal skill Excellent organizational, problem-solving, and communication abilitie Experience in analytical platform expansion (e.g., immunochemistry, qPCR, flow cytometry) is desirabl #J-18808-Ljbffr Kelly Science, Engineering, Technology & Telecom