Pharmaron Beijing Co. Ltd.
Principal Scientist - Analytical
Pharmaron Beijing Co. Ltd., Coventry, Rhode Island, us, 02816
We are seeking a Principal Scientist to join our team in Coventry, RI. The Principal Scientist, Analytical will spearhead manufacturing and process chemistry activities through the development, optimization, validation, and transfer of analytical methods, adhering to all relevant guidelines.
Primary Responsibilities:
Execute all tasks promptly and systematically in line with cGMP, GLP, and company policies.
Guarantee high-quality analytical work and document all pertinent information clearly and concisely following cGMPs.
Collaborate with internal and external stakeholders to address issues.
Develop, enhance, and/or validate robust, GMP-compliant analytical methods, documenting protocols and reports. - Engage in method transfer activities, including the composition of protocols and reports.
Conduct stability assessments and data analysis as needed.
Examine experimental data, lab notebooks, and instrument qualification protocols/reports.
Actively engage in investigations, problem-solving, and troubleshooting; author investigation reports.
Compile and present data summaries, both written and oral, as needed.
Effectively communicate critical analytical issues and solutions to cross-functional teams.
Operate and maintain analytical instruments and equipment following established procedures.
Uphold exemplary laboratory practices in line with safety and environmental standards.
Thrive in both team/matrix settings and independent work environments.
Carry out additional related tasks and duties as assigned.
Experience and Education
:
Have a PhD in Analytical Chemistry with 6 plus years of pharmaceutical analysis.
Experience with the following instrumentation: HPLC, GC, FTIR, UV, LC/MS, and wet chemistry.
Experience with NMR, ICP-MS, XRPD, DSC-TGA, LC/MS and/or GC/MS preferred.
Working knowledge of cGLP/cGMP and applicable FDA, EMA and ICH guidance preferred.
Excellent communication skills, both verbal and written.
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Primary Responsibilities:
Execute all tasks promptly and systematically in line with cGMP, GLP, and company policies.
Guarantee high-quality analytical work and document all pertinent information clearly and concisely following cGMPs.
Collaborate with internal and external stakeholders to address issues.
Develop, enhance, and/or validate robust, GMP-compliant analytical methods, documenting protocols and reports. - Engage in method transfer activities, including the composition of protocols and reports.
Conduct stability assessments and data analysis as needed.
Examine experimental data, lab notebooks, and instrument qualification protocols/reports.
Actively engage in investigations, problem-solving, and troubleshooting; author investigation reports.
Compile and present data summaries, both written and oral, as needed.
Effectively communicate critical analytical issues and solutions to cross-functional teams.
Operate and maintain analytical instruments and equipment following established procedures.
Uphold exemplary laboratory practices in line with safety and environmental standards.
Thrive in both team/matrix settings and independent work environments.
Carry out additional related tasks and duties as assigned.
Experience and Education
:
Have a PhD in Analytical Chemistry with 6 plus years of pharmaceutical analysis.
Experience with the following instrumentation: HPLC, GC, FTIR, UV, LC/MS, and wet chemistry.
Experience with NMR, ICP-MS, XRPD, DSC-TGA, LC/MS and/or GC/MS preferred.
Working knowledge of cGLP/cGMP and applicable FDA, EMA and ICH guidance preferred.
Excellent communication skills, both verbal and written.
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