Senior Bioanalytical Laboratory Specialist
4 days ago
We are seeking a highly skilled and experienced Laboratory Analyst to join our team at Novum Pharmaceutical Research Services. The successful candidate will be responsible for performing extraction of drugs/metabolites from bio-study samples, developing and validating bio-analytical methods, and operating laboratory equipment in accordance with GCP/GLP and OECD Series on Principles of Good Laboratory Practice.
Responsibilities:
- Perform extraction and bioanalysis of drugs and metabolites from biological samples in bio studies using LC-MS/MS, by established procedures and in compliance with GCP, GLP, OECD Series on Principles of Good Laboratory Practice, SOP, and regulatory guidelines
- Develop and validate bio-analytical methods under GCP/GLP and SOP guidelines using LC-MS/MS
- Operate calibrated laboratory instrumentation such as LC-MS/MS, HPLC, UPLC, UHPLC, LHS, balances, evaporators, centrifuges, etc. in accordance with SOP specifications.
- Perform calibration of laboratory instrumentation such as LC-MS/MS, HPLC, UPLC, UHPLC, LHS, pH meters, pipettes, etc.
- Perform development and validation of 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 scientists in performing root cause analysis and corrective action when experiment failure occurs.
- Preparation of Method SOPs, system SOPs, and instrument SOPs.
- Identify and report instrumental, analytical, health, and safety issues.
- Notify department management regarding omissions, incomplete results, or other irregularities.
- Documents and communicate any deviations from the instructions directly to the immediate Supervisor and/or if appropriate, the Principal investigator.
- Maintain training records, documenting training entries promptly.
- Work in a safe manner that does not endanger yourself and coworkers.
- Flexible to work in shifts, necessary to ensure completion of assigned tasks.
- Archival of Bioanalytical data.
- Responsibilities regarding the conduct of GCP/GLP and Non-GLP studies In addition to General Responsibilities, the following are additional responsibilities regarding the conduct of GCP/GLP and Non-GLP studies: Attachment 1 SOP NOV/QA/0001-1
- Generate analytical test results in compliance with all current SOPs, protocols, study plans, and applicable GLP (OECD), EMA, ICH, FDA, and TPD requirements.
- Document and communicate any deviations to these instructions directly to the Principal Investigator (for GLP studies) or Study Director (for Non-GLP studies).
- Record raw data promptly and accurately and in compliance with the OECD Principles of Good Laboratory Practice.
- Exercise health precautions to minimize risk and to ensure the integrity of the study.
- Communicate to the Laboratory Management any relevant known health or medical condition so he/she can be excluded from operations that may affect the study
Qualifications:
- 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, bioanalytical method validation, instrument calibration, and spreadsheet software.
- Excellent analytical skills are essential.
- Word processing is essential.
- Strong organizational skills.
- Good interpersonal skills.
- This position requires effective written and oral communication in the English language.
- Excellent report writing skills.
- Must be flexible and effective in the completion of tasks. Ability to retain and apply technical data and to source out required technical information of moderate complexity.
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