Analytical Scientist

6 hours ago

Hyderabad, Telangana, India PI Health Sciences Ltd Full time ₹ 15,00,000 - ₹ 20,00,000 per year

Team Leader : Bioanalytical Research Purpose of the Role: To lead and execute bioanalytical method development, validation, and sample analysis in support of preclinical and clinical studies within an Integrated Drug Discovery platform.

The role requires expertise in LC-MS/MS-based quantification of small molecules, biologics, or metabolites in biological matrices, adhering to GLP and regulatory compliance. Key Responsibilities: Strategic Responsibilities:

Design and implement bioanalytical strategies to support discovery and development programs. Collaborate with DMPK, discovery biology, medicinal chemistry, and regulatory teams in an integrated drug discovery model. Ensure regulatory compliance (GLP, GCLP, ICH, FDA, EMA) in method development and validation activities.

Operational Responsibilities: Develop and validate bioanalytical methods using LC-MS/MS for quantification of NCEs, biomarkers, or biologics in biological matrices (plasma, serum, tissues, etc.). Plan, execute, and troubleshoot sample analysis for PK, PD, and toxicokinetic studies.

Maintain accurate and compliant documentation including study plans, validation reports, SOPs, and analytical data. Perform instrument calibration, maintenance, and troubleshooting of LC-MS/MS and related equipment. Support the preparation of regulatory submissions (IND, NDA) by contributing to bioanalytical sections.

Team & People Responsibilities: Mentor and train junior scientists and analysts. Ensure safety protocols and lab discipline are followed.

Contribute to technical discussions and project reviews with cross-functional teams and clients. Qualifications & Experience: M.Sc / M.Pharm.

in Analytical Chemistry, Pharmaceutical Sciences, or Life Sciences. 4–10 years of relevant experience in a CRO / drug discovery setting. Proven hands-on expertise in LC-MS/MS, method development, and validation.

Experience with bioanalysis for discovery, preclinical, and/or early clinical programs. Familiarity with Watson LIMS or equivalent systems is a plus.

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