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.

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