Method Validation Research Chemist

Tris Pharma•Monmouth Junction, NJ

17h•Onsite

About The Position

Tris Pharma, Inc. is hiring Method Validation Research Chemists to work at its Monmouth Junction, New Jersey location. The role performs analytical testing and method validation activities in a regulated pharmaceutical laboratory, following company policies, SOPs, and applicable state, federal, and local laws. The chemist sets up, operates, cleans, maintains, and calibrates analytical instruments; conducts release, in-process, drug-product, stability, clinical-study, and cleaning verification/validation testing; and supports reference-standard qualification, method comparisons, validation, verification, and transfer. The position also prepares protocols and reports, processes and reports results using instrument-specific software, records work in laboratory notebooks and report sheets in compliance with cGDPs, cGMPs, and SOPs, and contributes to investigations and root-cause determinations. The role includes training junior chemists, tracking sample flow, maintaining an organized laboratory, meeting project deadlines, and complying with safety rules and DEA regulations. Background checks, including a drug screen, may be required.

Requirements

Bachelor’s degree in Chemistry or a related science field and 5 years of relevant experience in a Method Validation Laboratory under GMP regulation in the pharmaceutical industry; alternatively, a master’s degree in Chemistry or a related science field and 3 years of such experience.
Any suitable combination of education, training, or experience is acceptable.
At least 2 years of experience with spectroscopic and chromatographic techniques and concepts, and analytical instrumentation—including UV-Vis, IR, HPLC, UPLC, GC, ICP-MS, particle-size analyzers, and dissolution instruments—in a pharmaceutical manufacturing setting.
At least 5 years of experience with cGMP, FDA, and OSHA regulations and guidances.
At least 3 years of experience with quality systems, including change-control systems, analytical testing, calculations, and data analysis for in-process, resin-based extended-release liquid or solid dosage-form clinical-study samples, drug products, and stability samples.
Experience performing wet chemistry and physical testing of raw-material release samples according to pharmacopeia monographs in a regulated laboratory environment.
At least 2 years of experience performing and interpreting analytical results and laboratory investigations; cleaning verification/validation; reference-standard qualification analyses; method comparisons; interim analytical method validation; method validation, verification, and transfer; and preparation of associated protocols and reports.
Microsoft Office and Empower software skills.

Responsibilities

Set up and operate analytical instruments for sample testing, including HPLC, UPLC, GC, IR, UV/Vis, AA, TLC, Distek/Agilent instruments, ICP-MS, Karl Fischer, moisture balance, automatic and manual titration, viscosity and density meters, and a Malvern Particle Size Analyzer.
Test raw materials, including excipients and drug substances, for release using applicable analytical methods and USP/EP compendial monographs. Tests include assay, related substances, particle-size distribution, loss on drying, water content, residual ignition, residual solvents, optical rotation, pH, and viscosity.
Test in-process, drug-product, and stability samples in a GMP environment, including assay, blend/content uniformity, preservatives, related compounds, laser diffraction/sieve analysis, bulk and tapped density, and other applicable tests.
Test resin-based extended-release intermediates and liquid or solid dosage forms, including clinical-study samples.
Perform cleaning verification and validation testing, qualitative and quantitative analyses supporting reference-standard qualifications, method comparisons, and method validation, verification, and transfer.
Prepare validation, verification, and transfer protocols and reports, and perform analytical method interim validation.
Analyze samples using appropriate instrumentation and process and report results using instrument-specific data-processing software.
Perform calculations associated with test analyses.
Label, transcribe, and record testing details and results in laboratory notebooks and report sheets in compliance with current cGDPs, cGMPs, and SOPs.
Clean, maintain, and calibrate laboratory instruments to ensure compliance with cGLPs and cGMPs.
Clean and organize method-validation laboratory areas.
Train and mentor junior chemists in instrument operation and maintenance.
Participate in laboratory investigations and root-cause determinations.
Troubleshoot instrumentation problems, analytical anomalies, and laboratory investigations.
Track and maintain sample flow.
Comply with company policies and procedures, including safety rules and DEA regulations.
Meet project deadlines and performance standards.