HTI · 13 hours ago
Analytical Scientist III (Pharmaceutical)
Greenville, SC
Full-time
Onsite
Mid, Senior Level
$80K/yr - $95K/yr
6+ years expHTI is a large, well-established pharmaceutical manufacturing company seeking an Analytical Scientist III in Product Development. This role is responsible for developing, validating, and verifying complex analytical methods to support drug product release and stability testing, while ensuring compliance with FDA/ICH regulations.
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No H1B
Responsibilities
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
Qualification
Required
Bachelor's degree in Chemistry
6+ years of experience as an Analytical Chemist or Scientist working in pharmaceutical product development for oral medications, 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 preferred
HPLC, UPLC, GC, TLC, dissolution, particle size analysis, UV/Vis, FTIR, spectroscopy, titrations experience
Chromatography software (Empower, OpenLab, etc) experience
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 (SOP's, 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)
Preferred
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
Benefits
Fantastic benefits
Relocation assistance is available for qualified candidates
Company
HTI
Industrial Staffing | Professional & Skilled Hourly Recruiting | HR Services | Retention Strategies | Outplacement | Greenfield Start Ups & Expansions | Talent Management At HTI, we offer a wide range of support under the umbrella of people at work - walking beside employers to navigate the ins and outs of the employee lifecycle since 1999.
1001-5000 employees
Funding
Current Stage
Late StageLeadership Team
Herb Dew
CEO
John Knight
Owner & VP of Employment Solutions
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