Job Description

Senior Analytical Scientist (R&D/Product Development) position with a large, well-established pharmaceutical manufacturing company in Greenville, SC. This is a direct hire, full time, onsite role. Relocation assistance is available for candidates located outside of the greater Greenville, SC area. Salary is dependent upon education and experience. This company offers fantastic benefits, and a positive, team-oriented work environment.

Requirements:

• Bachelor’s degree in Chemistry
• 6+ years of experience as an Analytical Chemist or Scientist working in pharmaceutical product development/R&D with responsibility for the job duties listed below
• Must have experience developing and completing validation/verification of analytical methods to support product release and stability testing, and submitting products to the FDA
• Strong knowledge of cGMP and FDA regulations ; USP and ICH are a plus
• HPLC, UPLC, GC, TLC, dissolution, particle size analysis, UV/Vis, FTIR, spectroscopy, titrations experience
• Chromatography software experience (Empower, OpenLab, etc.)
• Strong MS Office and document management skills (Word, Excel, Adobe Acrobat for PDF editing)
• Must have professional verbal and written communication skills, with strong technical writing abilities for creating SOP’s, reports and FDA submittals
• Ability and desire to mentor and train junior team members
• Must be authorized to work in the United States without visa sponsorship (both now and in the future)

Additional experience that is a plus:

• Liquid oral solution/suspension experience
• ICP experience
• Mass spectrometry experience (MS, LC-MS, GC-MS, ICP-MS)
• Extractables/leachables identification for N-nitrosamines
• Previous experience in a Senior Scientist role
• Master’s degree in Chemistry

Job Summary:

Responsible for developing, validating, and verifying complex analytical methods to support drug product release and stability testing. This role includes designing and executing method validation/verification protocols and reports, preparing technical documentation (SOP’s, test methods, etc.) and independently managing projects all the way through to FDA submission. This team member will troubleshoot analytical challenges, provide technical solutions, and ensure compliance with FDA/ICH regulations.

Job Duties:

• Develop and complete validation/verification of complex analytical methods to support product release and stability testing
• Design, prepare, and execute method validation/verification and transfer protocols, reports, analytical methods, and SOPs, etc.
• Independently manage assigned projects
• Perform laboratory investigations and prepare necessary reports as needed
• Support timely deficiency responses
• Evaluating, troubleshooting, and improving existing analytical methods when necessary
• Maintain consistency with organizational objectives while providing imaginative and practicable technical solutions to an array of difficult problems
• Provide and receive peer reviews
• Train and mentor junior scientists on analytical techniques
• This employee will spend approximately 50% of their work time in the lab and the other 50% developing and writing SOP’s, technical documentation, FDA submittals, and reports
• Support other duties as assigned

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