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Research Scientist, Analytical R&D

Location : High Point, NC
Job Type : Direct
Reference Code : CRC_RSARD
Hours : Full Time
Required Years of Experience : 7+ years
Required Education : Bachelor's Degree
Travel : No
Relocation : No
Industry : Pharmaceutical

Job Description :

THE COMPANY:



  • Stable, high-growth specialized pharmaceutical manufacturer with a global presence and North American HQ

  • Comprehensive product/services offering to include end-to-end solutions for clients as a true one-stop-shop provider in their industry

  • Strong benefits offering to include medical/vision/dental, 401k, excellent PTO, and much more


THE SCOPE OF THE ROLE:



  • Develop 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


Required Qualifications :

THE BACKGROUND PROFILE:



  • PhD or MS in Chemistry (or closely related discipline) with 7+ years of experience; OR B.S. Degree in Chemistry with 10+ years of experience

  • Broad background with strong comprehension and demonstrated skills in the analytical methods validation/development areas

  • Aptitude in the area of Project Management is also a strong positive

  • 7+ years of experience in a cGMP environment

  • 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

  • Proficiency with Microsoft software (Word / EXCEL / PowerPoint) is expected


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