Our Client is seeking a highly motivated, energetic, results-oriented individual to join our GMP Analytical Laboratory team of dedicated professionals focused on customer service and quality. Relocation Assistance is available for the right candidate.
- Must be fully capable of developing/qualifying/validating analytical methods based on experience, first principles, sound theory, etc. Must demonstrate insight in design of experiments and gathering/interpreting data in order to deduce and/or test mechanistic or systematic hypotheses
- Design, develop, conduct and/or review experiments including method qualification/validation, method transfer, and unknown identification utilizing typical instrumentation including but not limited to LC, MS, GC, etc.
- Facility and experience in first-principle interpretation of results from IR, NMR, LC/MS data (structural elucidation/support to conclusions)
- Use/facility in various instrumental methods (IR, NMR, XRPD, TGA, KF, etc.) as well as non-instrumental methods (wet chemical methods)
- Write reports documenting outcomes of experiments/exercises
- Organize workflow and tasks to maximize laboratory efficiency (e.g., prioritize sample analysis, manage/assign tasks, preventative maintenance)
- Act as scientific, regulatory, technical or quality expert/liaison in team meetings and other settings by providing timely input to project activities/support to customers, responding to targeted questions, etc.;
- Participate in the laboratory quality system activities such as internal audits, writing standard operating procedures, and documentation review;
- Prepare samples for analysis and record data from analyses or experiments in a computer, log book, or laboratory notebook;
- Perform data audits in order to ensure accuracy of data and analytical processes;
- Provide leadership including cross-training and technical development to other laboratory colleagues as needed;
- Maintain laboratory equipment and instrumentation (e.g., troubleshooting, conducting preventative maintenance, calibrating and repairing);
- Ensure compliance with company policies and SOPs as well as FDA and other applicable guidelines.
- The successful candidate will hold a PhD or MS in Chemistry (or closely related discipline) with 5+ years’ relevant experience, or a BS degree with 10+ years’ relevant experience, having a broad background, strong comprehension, and demonstrated skills in the analytical methods validation/development areas.
- Aptitude in the areas of Project Management and Structural Elucidation
- A minimum of 7-10 years of relevant background in a cGMP-compliant pharmaceutical laboratory environment is required for consideration.
- In-depth work experience in an analytical contract laboratory environment is a strong positive.
- Experience in stability study performance/evaluation and/or knowledge/familiarity with USP/compendial testing is helpful.
- Excellent verbal and written communication/interpersonal skills, problem-solving skills, organizational skills, and the ability to work in a diverse team environment are essential.
- Proficiency with Microsoft software (Word / EXCEL / PowerPoint) is expected.