Bioanalytical Manager

Bioanalytical ManagerAbout the Role

We are seeking an experienced and highly motivated Bioanalytical Manager to lead bioanalytical operations within our Bioavailability/Bioequivalence (BA/BE) research facility. The successful candidate will be responsible for managing bioanalytical studies, ensuring regulatory compliance, overseeing method development and validation activities, and leading a team of scientists to deliver high-quality results within project timelines.

Experience

• Minimum 7 years of experience in Bioanalytical Research within a CRO, pharmaceutical, or clinical research environment.
• Strong hands-on experience in BA/BE studies involving LC-MS/MS analysis of small molecules.
• Prior experience in team leadership and regulatory audits is preferred.

Key Responsibilities

• Manage end-to-end bioanalytical activities for BA/BE studies in compliance with applicable regulatory guidelines.
• Oversee bioanalytical method development, method validation, sample analysis, and data review activities.
• Ensure compliance with GLP, GCP, NABL, CDSCO, US FDA, EMA, ANVISA, and other applicable regulatory requirements.
• Review analytical protocols, validation reports, study reports, SOPs, and related documentation.
• Lead and mentor bioanalytical scientists, analysts, and laboratory personnel.
• Coordinate with Clinical, Project Management, QA, and Regulatory teams to ensure timely study execution.
• Support client discussions, project feasibility assessments, and technical proposal preparation.
• Participate in regulatory inspections, sponsor audits, and internal quality audits.
• Drive laboratory productivity, process improvements, and operational excellence initiatives.
• Ensure proper maintenance, qualification, and utilization of LC-MS/MS and associated laboratory equipment.
• Monitor study timelines, resource allocation, and laboratory performance metrics.

Required Qualifications

• M.Pharm, M.Sc., Pharm.D, or equivalent qualification in Pharmaceutical Sciences, Analytical Chemistry, Biotechnology, or related disciplines.
• Strong expertise in LC-MS/MS instrumentation and bioanalytical techniques.
• Thorough understanding of current regulatory expectations for bioanalytical method validation and sample analysis.
• Excellent leadership, communication, problem-solving, and project management skills.

Preferred Skills

• Experience handling multiple sponsor projects simultaneously.
• Exposure to pharmacokinetic data interpretation and BA/BE study requirements.
• Experience managing regulatory inspections and client audits.
• Knowledge of Watson LIMS, Analyst, MassLynx, or similar bioanalytical software platforms.

What We Offer

• Opportunity to lead a growing bioanalytical team.
• Exposure to global regulatory projects and sponsor interactions.
• Collaborative and scientifically driven work environment.
• Career growth and leadership development opportunities.