PAI Pharma · 4 hours ago
Analytical Scientist III
Greenville, SC, US
Full-time
Onsite
Senior Level
6+ years expPAI Pharma is a company focused on pharmaceutical development, and they are seeking an Analytical Scientist III. This role involves developing and validating analytical methods, managing projects, and ensuring compliance with industry standards.
B2BBiotechnologyHealth CareManufacturingMedicalPharmaceuticalWholesale
Responsibilities
Focus on various separation science platforms such as HPLC/UPLC, GC and GC-HS, with a focus on degradation/impurity analysis, API/Preservative Assays and Residual Solvent analysis
Develop and complete validation/verification of complex analytical methods to support product release and stability testing
Design, prepare, and execute method validation/verification protocols and reports, analytical methods, and SOPs. Ensure that the documents adhere to GDP requirements and ICH guidelines
Demonstrate ability to independently:
Manage assigned projects
Conduct troubleshooting
Perform laboratory investigations and prepare necessary reports as needed
Advanced ability in
Supporting timely deficiency responses
Evaluating, troubleshooting, and improving existing analytical methods when necessary
Demonstrates strong ability to maintain consistency with organizational objectives while providing imaginative and practicable technical solutions to an array of difficult problems
Proficiency in basic laboratory techniques such as: pH, Karl Fischer, UV/Vis, FTIR, Particle Size Analysis, etc
Demonstrates ability to assist in training junior scientists on analytical techniques
Maintain a GMP compliant laboratory environment
Interface with third-party contract laboratories
Qualification
Required
Skill and knowledge of various separation science platforms such as HPLC/UPLC, GC and GC-HS
Focus on degradation/impurity analysis, API/Preservative Assays and Residual Solvent analysis
Develop and complete validation/verification of complex analytical methods to support product release and stability testing
Design, prepare, and execute method validation/verification protocols and reports, analytical methods, and SOPs
Ensure that the documents adhere to GDP requirements and ICH guidelines
Ability to independently manage assigned projects
Conduct troubleshooting
Perform laboratory investigations and prepare necessary reports as needed
Advanced ability in supporting timely deficiency responses
Evaluating, troubleshooting, and improving existing analytical methods when necessary
Strong ability to maintain consistency with organizational objectives while providing imaginative and practicable technical solutions
Proficiency in basic laboratory techniques such as: pH, Karl Fischer, UV/Vis, FTIR, Particle Size Analysis, etc
Ability to assist in training junior scientists on analytical techniques
Maintain a GMP compliant laboratory environment
Interface with third-party contract laboratories
Expertise and proven ability to apply knowledge to establish analytical methods as per FDA guidelines
Strong background in HPLC/UPLC, GC and GC-HS
Excellent instrument and method troubleshooting skills
Knowledge of various data analysis approaches
Proficiency with the use of chromatographic software applications such as Syngistix, OpenLab, and Empower
Proven ability to adhere to good documentation standards and maintain detailed records of all work performed
Proven capability of evaluating/developing new technologies in an independent manner
Ability to propose/design implementation strategies if deemed appropriate
Independent, self-driven team player ready to provide guidance and mentorship to junior staff
Preferred
Experience with and/or knowledge of the regulatory requirements including knowledge of appropriate control and testing strategies
Working experience in a GMP environment and ability to adhere to all appropriate GMP standards
Company
PAI Pharma
PAI Pharma develops, manufactures and distributes liquid pharmaceuticals to create healthier lives.
501-1000 employees
H1B Sponsorship
PAI Pharma has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2023 (2)
2022 (1)
Funding
Current Stage
Late StageTotal Funding
unknown2025-02-13Acquired
2019-11-06Private Equity
Leadership Team
Kurt Orlofski
CEO
Domenic Ciarico
Chief Commercial Officer (CCO)
Recent News
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