Senior Analyst - Bioanalytical Research

Roles & Responsibilities

Perform Analysis:

• Collect samples for analysis from Custodian.
• Processing of samples by using various sample extraction technique (to determine the concentration of analyte).
• Batch sequence preparation and verification in coordination with LIMS Operator.
• Perform analysis via LCMS/ ICP-OES/ ICP-MS. Follow GxP.
• Mass Spectrometry operation and ESI, APCI conceptual clarity.
• Chiral chromatography, polar columns conceptual clarity.
• Sample extraction process using LLE, SPE, and PPT.

Documentation and compliance:

• Receive controlled forms for various activities.
• Perform online documentation of development trial in Method Book (Laboratory Record Book), validation experiment documentations, entry in log books in control forms as per SOP, evaluate experiment outcome with pre-defined validation/ study protocol.
• Document all linked activities and forms as per SOP.
• Investigation approach in case of abnormality.
• Regulatory response and investigation writing skills.
• To check the documentation done by Jr. Analyst/ fresher.
• Solve the finding/ observation raised by the QC and QA in timely manner.

Research & Development:

• Literature review i.e., published pharmacopeia guidelines/ research documents received from GL and SGL.
• Validation: Perform experiments as per protocol.
• Method development skills.
• Troubleshooting of method.
• Excel and MS-Word.

Equipment Calibration :

• To calibrate lab equipments like micro-pipettes, analytical balance, pH meter, evaporators, roto spin extractor, centrifuge, Solid Phase Extraction (SPE) assembly and their performance check as and when required, to coordinate with engineer for any breakdown pertaining to lab equipment.

Training :

• To coordinate assist/ support in on-the-job trainings for fresher.
• Regulatory guidelines and thorough training on SOPs.
• Presentation skill.
• Regulatory updates and latest guidance awareness.
• To understand GCP and GLP requirement and its awareness.
• General biosafety procedures, emergency procedures awareness.
• Knowledge of organization policies/ values.

Desired Candidate Profile:

• Education: B.Pharm, M.Pharm, M.Sc
• Experience: 1-5 Years' experience in CRO.