Method Validation Research Chemist

Tris Pharma Inc•South Brunswick, NJ

1d•$113,589 - $127,500•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 work in a regulated pharmaceutical laboratory, in accordance with company policies, SOPs, and applicable state, federal, and local laws. The chemist operates analytical instruments to test raw materials, in-process materials, drug products, stability samples, resin-based extended-release intermediates and dosage forms, and clinical study samples. Testing includes assays, related substances and compounds, content uniformity, particle-size analysis, loss on drying, water content, residual ignition and solvents, optical rotation, pH, viscosity, density, and other tests specified by analytical methods and pharmacopeial monographs. The role also supports cleaning verification and validation, reference-standard qualification, method comparisons, and analytical method validation, verification, transfer, and interim validation. The chemist prepares protocols and reports, processes and reports results using instrument-specific software, performs calculations, and records testing details and results in laboratory notebooks and report sheets in compliance with current cGDPs, cGMPs, and SOPs. The position also involves maintaining and calibrating instruments, keeping laboratory areas clean and organized, training and mentoring junior chemists, participating in investigations and root-cause determinations, troubleshooting instrumentation and analytical issues, tracking sample flow, and meeting project deadlines and performance standards. Compliance with company safety policies and DEA regulations is required. Background checks, including a drug screen, may be conducted.

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. A 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.
5 years of experience with cGMP, FDA, and OSHA regulations and guidances.
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 and solid dosage-form clinical study samples, drug products, and stability samples.
Experience performing wet chemistry and physical testing of raw materials according to pharmacopeial monographs in a regulated laboratory environment.
Experience with cleaning verification and validation, reference-standard qualification, method comparisons, analytical method interim validation, method validation, verification, and transfer.
Experience preparing validation, verification, and transfer protocols and reports.
At least 2 years of experience performing and interpreting analytical results and laboratory investigations.
Microsoft Office and Empower software skills.

Responsibilities

Perform work in accordance with company policies, SOPs, and applicable state, federal, and local laws.
Set up and operate analytical instruments for sample testing, including HPLC, UPLC, GC, IR, UV/Vis, AA, TLC, ICP-MS, Karl Fischer, moisture balance, automatic and manual titration, viscosity and density meters, particle-size analyzers, and dissolution instruments.
Test raw materials, including excipients and drug substances, for release according to analytical methods and USP/EP compendial monographs.
Test in-process materials, drug products, and stability samples, including assay, blend and content uniformity, preservatives, related compounds, laser diffraction and sieve analysis, and bulk and tapped density.
Test resin-based extended-release intermediates and liquid and solid dosage forms, including clinical study samples.
Perform cleaning verification and validation testing.
Conduct qualitative and quantitative analyses to support reference-standard qualifications and method comparisons.
Perform analytical method interim validation, validation, verification, and transfer.
Prepare validation, verification, and transfer protocols and reports.
Analyze samples with 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 on instrument operation and maintenance.
Participate in laboratory investigations and root-cause determinations.
Troubleshoot instrumentation issues, 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.