The incumbent will conduct bio-analytical projects, including sample preparation, perform general laboratory procedures, maintain/calibrate and operate laboratory equipment in accordance with GCP/GLP and OECD Series on Principles of Good Laboratory Practice.
- Perform extraction of drugs and metabolites from biological matrices, by established procedures and in compliance with GCP,GLP, OECD Series on Principles of Good Laboratory Practice, SOP and regulatory guidelines. Well versed with the extraction techniques includes but not limited to, protein precipitation, liquid-liquid extraction, supported liquid extraction solid phase extraction, derivatization etDeveloping and support validation of bio-analytical methods under GCP/GLP and SOP guidelinesusing LC-MS/MSOperate and maintain calibrated laboratory instrumentation such as LC-MS/MS, balances, evaporators, centrifuges, pipettes, pH meter etc. in accordance with SOP specifications.
- Perform project specific laboratory documentation (e.g. laboratory logbooks/ worksheets, analytical data, project notes/forms/memos) for assigned projects and regulatory submissions and in compliance with the Principles of Good Laboratory Practice and responsible for the quality of the data.
- Assist Research scientist to perform root cause analysis and corrective action when batch failure occurs.
- Participate in general laboratory operational duties such as freezer records, reference standard material records, chemical inventory records, and laboratory supplies as assigned.
- Identify and report instrumental, analytical, health and safety issues.
- Notify department management regarding omissions, incomplete results or other irregula
- Documents and communicate any deviations from the instructions directly to the immediate Supervisor and/or if appropriate, the Principal investigator.
- Maintain training binder, documenting training entries promptly.
- Work in safe manner that does not endanger yourself and coworker.
- Flexible to work in-shifts, necessary to ensure completion of assigned tasks.
- Archival of Bioanalytial data
- Perform other duties as assigned
- Has completed a Bachelor of Science or college program in analytical chemistry, or pharmaceutical sciences with chemistry laboratory exposure.
- 2-5 years experience in the Pharmaceutical industry is required. Knowledge of extraction procedures, method validation, instrument calibrationandspreadsheet software.
- Excellent analytical skills are essential.
- Word processing is essential.
- Strong organizational skills
- Good interpersonal skills
- This position requireseffective written and oral communicationsin the English language.
- Excellent report writing skills.
- Must be flexible and effective in completion of Ability to retain and apply technical data and to source out required technical information of moderate complexity.
- 2-5 years experience in the Pharmaceutical industry
- Chemistry laboratory exposure.