Clinical Research Manager jobs in Gastonia, NC

Position Summary:

The Research Scientist, Clinical - Analytical is responsible for developing and validating or verifying methods for raw materials and for drug product utilizing the appropriate analytical technique in compliance with local procedures, corporate policies, and the regulatory requirements of the US Food and Drug Administration. 

Job Responsibilities:

• Develop and Validate/Verify methods for various analytical techniques in accordance with FDA guidance documents
• Draft and review technical documents supporting development and release such as method validation/verification protocols and reports
• Perform analysis of R&D samples
• Utilize analytical instrumentation such as FTIR, HPLC, UPLC, GC-MS, ICP-MS, AA, and UV/VIS and have a scientific understanding of these techniques
• Perform instrument and method troubleshooting as needed
• Support investigations on studies that have unusual results, and on out-of-trend and out-of-specification results
• Provide technical leadership and train technicians and other chemists on analytical methods, instruments, and documentation
• Perform all activities in compliance with cGLP/cGMP requirements
• Assume other responsibilities as assigned by area management
• Manage activities with good time management maximize productivity
• Support the ongoing development, manufacture, and distribution of pharmaceutical products
• Involvement with the transportation and handling of hazardous waste, as needed
• Must successfully complete RCRA training within 1 year of hire date and annually thereafter
• Perform other duties as assigned

Required Skills:

• Excellent attention to detail and working knowledge of FDA Regulations/Guidance’s, 
• Good Laboratory Practices, Good Manufacturing Practices, and ICH Guidelines, USP/NF
• Excellent verbal and written communication, organization, time-management, display sound judgment, problem-solving, interpersonal and analytical skills.
• Able to mentor and train junior scientists
• Working knowledge of Equipment software such as Empower

Education and Experience Requirements: 

• PhD or master’s degree in chemistry or related scientific discipline with 2 – 5 years of relevant Analytical Chemistry experience, in the pharmaceutical industry or a CRO. 

EOE Disability/Veterans