Analytical Scientist III; Pharmaceutical manufacturing

Overview

HTI is recruiting an experienced Analytical Scientist III (R&D/Product Development) for a large, well-established pharmaceutical manufacturing company in Greenville, SC. This company offers fantastic benefits, and a positive, team-oriented work environment. This is a direct hire, full time, onsite role. The salary range starts at $85,000 / year, and is dependent upon experience and education. This employee may choose their work schedule based on their preference (7am-4pm, 7:30-4:30am, 8am-5pm, or 8:30-5pm).

Relocation assistance is available for candidates located outside of the greater Greenville, SC area.

• 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
• Independently manage assigned projects
• Perform laboratory investigations and prepare necessary reports as needed
• Support timely deficiency responses
• Evaluate, troubleshoot, and improve existing analytical methods
• Maintain consistency with organizational objectives while providing technical solutions to problems
• Provide and receive peer reviews
• Train and mentor junior scientists on analytical techniques
• Spend approximately 50% of time in the lab and 50% developing and writing SOPs, technical documentation, FDA submittals, and reports
• Support other duties as assigned

• Bachelor’s degree in Chemistry
• 6+ years of experience as an Analytical Chemist or Scientist in R&D or product development within the pharmaceutical manufacturing industry with responsibility for the listed duties
• 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 preferred
• Experience with HPLC, UPLC, GC, TLC, dissolution, particle size analysis, UV/Vis, FTIR, spectroscopy, and titrations
• Chromatography software experience (Empower, Open Lab, etc.)
• Strong MS Office and document management skills (Word, Excel, Adobe Acrobat for PDF editing)
• Professional verbal and written communication skills, with strong technical writing abilities (SOPs, reports, 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)

• 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: The Analytical Scientist III (Pharmaceutical Product Development) is 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/reports, preparing technical documentation (SOPs, test methods, etc.) and independently managing projects all the way through to FDA submission. The Analytical Scientist III troubleshoots analytical challenges, provides technical solutions, and ensures compliance with FDA/ICH regulations.

• 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
• 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 SOPs, technical documentation, FDA submittals, and reports
• Support other duties as assigned

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