Posted on Nov 14, 2018 by Affinity Executive Search
* -Must be fully capable of developing analytical methods based on experience, literature search, etc.
* -Design, develop, conduct and/or review experiments including method development and method
* transfer; perform methods validations utilizing typical instrumentation including but not limited to LC,
* MS, GC, etc.
* -Interpret data from routine and non-routine analyses in order to develop workable test methods
* and/or deduce and test mechanistic or systematic hypotheses;
* -Familiarity with other instrumental methods (IR, NMR, XRPD, TGA, KF, etc.) as well as non-
* instrumental methods (wet chemical methods);
* -Perform data audits in order to ensure accuracy of data and analytical processes;
* -Act as scientific, regulatory, technical or quality expert and consultant by responding to targeted
* questions from and providing support to customers;
* -Provide leadership including cross-training and technical development to the GMP Analytical laboratory colleagues;
* -Organize workflow and tasks to maximize laboratory efficiency (e.g., prioritize sample analysis, manage/assign tasks, preventative maintenance);
* -Maintain laboratory equipment and instrumentation (e.g., troubleshooting, conducting preventative maintenance, calibrating and repairing);
* -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;
* -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 7-10 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 area of Project Management is also a strong positive. 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 is helpful. Demonstrated project management skills is also a strong positive. Expertise in USP/compendial testing is vital. Excellent verbal and written communication/interpersonal skills, problem-solving skills, organizational skills, and the ability to work in a diverse team environment are essential.
Affinity Executive Search
RAI Services Company
Affinity Executive Search