Director of Bioanalysis- LCMS

Resolian • Malvern, AR

92d

About The Position

The position involves providing scientific and operational leadership to the LC-MS/MS Bioanalysis team. The successful candidate will oversee the design, validation, and execution of bioanalytical methods for small molecules, biomarkers, and metabolites, ensuring compliance with GLP, GCP, and regulatory agency guidelines such as FDA, EMA, and ICH. The role includes managing and mentoring a team of scientists and analysts, collaborating with project management and clients to meet study timelines and deliverables, and developing and optimizing laboratory processes and resource allocation. Additionally, the candidate will be responsible for authoring, reviewing, and approving study protocols, validation reports, bioanalytical reports, and SOPs, serving as a scientific liaison during client audits and regulatory inspections, and driving innovation to evaluate new technologies to expand departmental capabilities.

Requirements

• PhD or MS in Analytical Chemistry, Biochemistry, Pharmacology, or related field.
• 10+ years of bioanalytical experience with LC-MS/MS, including at least 5 years in leadership.
• Strong knowledge of GLP/GCP regulations and regulatory submission requirements.
• Demonstrated success managing teams in a fast-paced CRO or pharma environment.
• Excellent problem-solving, communication, and client-facing skills.

Nice To Haves

• Experience with LIMS, electronic data capture, and workflow management systems.

Responsibilities

• Provide scientific and operational leadership to the LC-MS/MS Bioanalysis team.
• Oversee design, validation, and execution of bioanalytical methods for small molecules, biomarkers, and metabolites.
• Ensure all studies are conducted in compliance with GLP, GCP, and regulatory agency guidelines (FDA, EMA, ICH).
• Manage and mentor a team of scientists and analysts, fostering technical growth and accountability.
• Collaborate with project management and clients to meet study timelines and deliverables.
• Develop and optimize laboratory processes, instrumentation utilization, and resource allocation.
• Author, review, and approve study protocols, validation reports, bioanalytical reports, and SOPs.
• Serve as a scientific liaison during client audits and regulatory inspections.
• Drive innovation and evaluate new technologies to expand departmental capabilities.

What This Job Offers

• Education Level: Ph.D. or professional degree
• Number of Employees: 251-500 employees