ONSITE ROLE

Position Summary

Key responsibility of the position is performing data and report quality checks (QC), managing lab operations such as inventory and supply ordering, maintaining lab equipment, and coordinating with vendors for scheduled and unscheduled maintenance. In addition, this position plays a critical role in the development and execution of bioanalytical assays to support drug development and regulatory submissions. Responsibilities include quantitative analysis of drugs and metabolites in biological matrices (e.g., plasma, tissue) using LC-MS/MS and HPLC, in compliance with global regulatory standards. The role contributes to studies in pharmacokinetics, metabolism, food safety, efficacy, and target animal safety.  

Key Responsibilities

• Performs quality checks (QC) of bioanalytical data and reports, manage routine lab operations including inventory management and lab supply ordering, maintenance of lab equipment, coordinate with external vendors for planned and unplanned maintenance.
• Develop, validate, and perform bioanalytical methods using LC-MS/MS and HPLC to support sample analysis for regulatory and non-regulatory studies.
• Troubleshoot and maintain laboratory instruments in a validated state.
• Ensure strict adherence to SOPs and company policies, animal welfare, and other regulatory guidelines (GLP/GCP).
• Prepare detailed method descriptions, technical reports, and regulatory documentation.
• Interpret and review technical data with limited supervision.
• Draft study reports and contribute to SOP development and review.
• Design and execute non-routine experiments and propose new technologies.
• Stay current with scientific literature and attend relevant meetings.
• Mentor junior scientists and technicians.
• Serve as Investigator or Principal Investigator for studies.
• Collaborate across global bioanalytical teams and cross-functional stakeholders.
• Support lab operations including inventory management and supply ordering.
• Promote and maintain a safe working environment in accordance with HSE policies.

Required Skills

The ideal candidate will demonstrate expertise in several of the following areas:

• Lab management, scientific reporting, and data quality checks (QC)
• Prior pharmaceutical industry R&D experience
• Strong foundation in analytical/bioanalytical techniques including chromatography, mass spectrometry, and sample extraction
• Hands-on experience with LC-MS/MS and HPLC instrumentation
• Proven ability to develop, validate, and execute analytical methods
• Familiarity with GLP and regulatory standards (FDA, EMEA)
• Experience in planning and reporting bioanalytical studies
• Effective written and verbal communication skills
• Proficiency in scientific software and data analysis tools

Ability to work independently and within cross-functional teams

Education:

• Master’s degree in Chemistry, Analytical Chemistry, Biochemistry, or related field with 1+ years of relevant experience, OR
• Bachelor’s degree with 3+ years of relevant experience