Reporting directly to the Director - Chemistry, the Analyst II will be responsible for providing basic technical support and analysis within the Biopharmaceutical Chemistry Testing Laboratory. This is a deadline-based, high-pressure work environment with on-going projects for a variety of clients.
The Analyst II will have over 2 to 7 years of laboratory testing experience with demonstrated ability to complete role/duties that are more complex. Has handled variety of instrumentations for analytical testing and will be able to work independently with minimal/no supervision. The incumbent must be energetic, exceedingly well-organized, flexible, and must have the ability to interact with customers and staff in a fast-paced environment, sometimes under pressure, while remaining proactive, resourceful, and efficient. A high level of professionalism and confidentiality is crucial to this role.
The Analyst II must:
- Proficient in operating GCMS or GCMSMS and GC instruments with headspace FID and TCD detectors.
- Perform method development, method validation, method transfer and routine analyses using GC-MS/MS and GC-FID instrumentation.
- Learn and apply knowledge with additional advanced instrumentation techniques (HPLC, LC-MS/MS, ICP-MS, etc.) and software (Waters, Chromeleon, Analyst, Mass Hunter) as necessary
- Ensures that all work is carried out in compliance with company Safety policies, Good Manufacturing Practices (GMP/GLP) and Standard Operating Procedures (SOPs).
- Perform instrument calibration, qualification and preventative maintenance program as necessary.
- Analyze API, Raw Materials and Finished products for Assay, Impurities/ Residual solvents/ Pesticide analysis using GC instrument with minimum or no supervision.
- Recognizes OOS or out of trend results and assists laboratory manager in the completion of lab investigations.
- Calibrate instruments.
- Process and report analytical results.
- Update and report work into LIMS.
- Review technical data, documents, and proposals as required.
- Proficient in Microsoft office programs (Outlook, Word, and Excel).
- Hands on experience with pharmaceutical data acquisition software e.g. Chromeleon, Mass hunter, e-LIMS, eQMS etc.
- Troubleshoot technical issues/ difficulties with methods.
- Co-ordinate with team members to perform method transfers between R&D group to QC group.
- Promote and maintain a safe and healthy working laboratory environment in compliance with established health and safety procedures.
- Strong interpretation of routine analysis or tests.
- In-depth understanding of chromatography principles, types and techniques.
- Have high troubleshooting skills, both with instruments and methods.
- Apply technical judgment to determine potential problems for samples.
- Track instrument quality control.
- Appropriately follow safety, operational integrity and quality control requirements for the work that is done.
- Be able to work under GMP guidelines, and be proficient with USP and pharmaceutical testing.
- Explaining latest, applicable methods and techniques to perform various experiments and teaching necessary techniques that need to be adopted to complete a particular experiment or an allotted assignment.
- Competent research and study skills to learn about innovative methodologies and equipment used for problem solving and troubleshooting.
- Accountable for the integrity and traceability of all data generated and reported
- Design, preparation, and production of study materials including procedure manuals.
- Perform other duties as assigned by Laboratory manager.
Key Responsibilities:
- Sample preparation and Mobile phases preparation.
- Documentation: Ensuring accurate reporting in lab books.
- Using a wide range of sophisticated equipment and instruments to conduct analysis and research and trouble shoot instrumentation/methods
- Perform other departmental tasks such as cleaning, supply ordering, assist with instrumentation training and maintenance, etc
- Perform analytical tests utilizing GC, HPLC/UPLC, UV, IR, FTIR, KF and other laboratory instruments.
- Assess, compare and perform risk assessments for compendial method compliance according to USP, EP, and other regulations
- Mentoring/training junior staff members and Imparting training to new recruits for operation, calibration and preventive maintenance of GC/GCMS/ HPLC/ LC-MS/MS, etc .
- Writing SOPs
- Ensure that work is performed in compliance with good manufacturing practices (GMP), standard operating procedures (SOPs) and the current test method.
- Participates in general lab duties, including clean up, administration, logbook review and operations support