Senior Analytical Chemist

Polysciences, Inc.; Warrington Township (Bucks County); On-site; USD 90,000 - 120,000; Full time

Job summary

Polysciences, Inc. seeks a Senior Analytical Chemist to independently develop analytical methods suitable for validation and to prepare validation protocols with ICH, USP and other regulatory standards in mind.

The role involves method validation/verification, transferring validated methods to Quality Control, routine testing, and updating SOPs to improve lab functions. Mentoring junior team members is also expected.

Qualifications

• 4+ years in industry developing analytical methods.
• Experience validating analytical methods.
• Experience in ISO or FDA-regulated environments.
• Knowledge of USP, ICH guidelines and compendial methods.
• Ability to mentor junior team members.

Responsibilities

• Develop methods aligned with customer specifications and regulatory requirements.
• Draft test methods, protocols and reports per USP/ICH guidelines.
• Provide technical review of junior staff notebooks and data.
• Maintain and troubleshoot analytical instrumentation (LC/GC/NMR/GPC, MS systems).
• Update SOPs to support continuous improvement and ALCOA+ data integrity.

Skills

Analytical method development

Mentorship

Lab troubleshooting

Education

Bachelor's in Chemistry

Master's in Analytical Chemistry

PhD in Analytical Chemistry

Tools

LC

GC

NMR

GPC

LC-MS

GC-MS

ICP-MS

Job description

The Senior Analytical Chemist primary responsibility is independent development of analytical methods that are suitable for validation and preparing for validation by drafting Test Methods, method validation or verification protocols with ICH, USP and other regulatory standards in mind. Other responsibilities also include: execution of method validations or verifications, drafting of method validation or verification reports, transferring validated test methods via hands-on training to the Quality Control department, routine testing following established Test Methods, updating Standard Operating Procedures to improve lab functions, perform troubleshooting on Analytical R&D laboratory equipment, review of colleague's laboratory notebooks, and investigation into materials and/or processes to support other Polysciences departments. The ideal candidate will be quality-focused, collaborative and capable of mentoring or training junior team members in areas of expertise.

Essential Functions:

• Independent development of methods, supported by literature research, to align with customer specifications and other business needs.
• Independent drafting of test methods, protocols and reports in alignment with USP, ICH and other regulatory best practices.
• Technical review of junior lab member's laboratory notebooks and data.
• Routine maintenance of laboratory equipment, including but not limited to LCs, GCs, NMR, and GPCs.
• Revising current Standard Operating Procedures and internal documentation to support Continuous Improvement.
• Maintain laboratory notebooks and development reports with ALCOA+ in mind.
• Experience with set-up and analysis using GC-MS and LC-MS systems.
• Experience with NMR, ICP-MS and GPC analyses and theory.
• Mentorship of junior lab members.
• 60 - 85% of day-to-day activities will be in the laboratory.

Qualifications

• Bachelor's Degree in Chemistry, plus 4+ years of industry experience with at least 3 years of experience developing analytical methods or independently validating analytical methods.
• Master degree in Analytical Chemistry, plus 1+ years of industrial experience developing analytical methods or performing validation activities.
• Ph.D. degree in Analytical Chemistry, plus experience developing analytical methods or performing validation activities.
• Experience working in an ISO or FDA regulating environment.
• Experience verifying and troubleshooting analytical methods in an ISO 9001/ISO 13485 or FDA GMP regulated environment required.
• Knowledge of compendial methods (ie. USP, EP, ISO, ASTM and or ANSI) and ICH guidelines and applications.