Laboratory Manager

Position Summary:

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

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Qualification

• s:Bachelor’s or Master’s degree (or higher) in Chemistry, Biochemistry, Biology, Pharmaceutical Sciences, or related disciplin
• e.Minimum 5 years’ experience in a regulated bioanalytical laboratory (GLP/GCP/GMP), with clear progression in technical and/or leadership role
• s.Proficiency with bioanalytical platforms (especially LC-MS/MS, immunochemistry); experience managing lab teams supporting preclinical and clinical studie
• s.Familiarity with the implementation and use of eQMS/LIMS system
• s.Strong working knowledge of regulatory requirements (FDA, EMA, ICH M10) and best laboratory practice
• s.Demonstrated leadership, team management, and interpersonal skill
• s.Excellent organizational, problem-solving, and communication abilitie
• s.Experience in analytical platform expansion (e.g., immunochemistry, qPCR, flow cytometry) is desirabl