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Associate Director of Analytical R&D (Early Phase Pharmaceutical Small Molec

Company: Kelly Services
Location: High Point
Posted on: December 1, 2018

Job Description:

Kelly Services is currently seeking a DIRECT HIRE Associate Director of Analytical R&D (Early Phase Pharmaceutical Small Molecules) for an esteemed client located in High Point, NC to join our Analytical R&D team in the small molecule arena. Direct Hire Benefits Relocation Assistance The ideal candidate will 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 Job Description: Manage/coordinate/drive efforts of staff in conjunction with approved quotes and plant scheduling; ensure adherence to agreed-upon deadlines; timely invoicing of work. Assure compliant, staffed analytical laboratory support. Recommend/justify new/additional equipment, upstaffing or organizational positions, promotions. Develop/maintain/improve Analytical Procedures/SOPs/systems/procedures/similar. Ensure training, development, and mentoring of laboratory colleagues. Represent GMP Analytical in production meetings, customer discussions, etc. Lead larger-scope projects. Additional Job Details: 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/or 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. Qualifications: The successful candidate will hold a PhD or MS in Chemistry (or closely related discipline) with 5 years of demonstrated success in leading teams and managing projects along with 7 years relevant analytical experience in a cGMP-compliant pharmaceutical laboratory environment. BS degree may be considered only with exceptional experience. Broad background, strong comprehension, and demonstrated skills in analytical methods development/validation/transfer/similar, reference standards characterization/structural elucidation, and unknown identification. 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.

Keywords: Kelly Services, High Point , Associate Director of Analytical R&D (Early Phase Pharmaceutical Small Molec, Executive , High Point, North Carolina

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