Method Validation Research Chemist

Tris Pharma, Inc.; South Brunswick (NJ); On-site; USD 114,000 - 128,000; Full time

Job summary

Tris Pharma, Inc. in Monmouth Junction, NJ is seeking a Method Validation Research Chemist to set up and operate analytical instruments, validate methods, and support release and stability testing in a GMP laboratory.

The role requires hands-on use of HPLC, GC, UV/Vis, IR, KF, ICP-MS and other instruments. Responsibilities include preparing validation protocols, performing test analyses, reviewing results, and contributing to investigations while training junior staff.

Qualifications

• Bachelor's or Master's degree in chemistry or related field with GMP pharma experience.
• Experience with analytical method validation and transfer under GMP.
• Knowledge of spectroscopic and chromatographic techniques and instruments.

Responsibilities

• Set up and operate analytical instruments for sample testing (HPLC, GC, IR, UV/Vis, KF, ICP-MS).
• Prepare validation/verification/transfer protocols and reports.
• Perform method validation and verification activities for drug substances and dosage forms.
• Analyze results, document in lab notebooks, and ensure cGDP/cGMP compliance.
• Train and mentor junior chemists and participate in investigations.

Skills

Spectroscopic/Chromatographic skills

Analytical instrumentation

Regulatory compliance (cGMP, FDA, OSHA

Data analysis and calculations

Education

Bachelor's degree in Chemistry or related science

Master's degree in Chemistry or related science

Tools

HPLC

UPLC

GC

ICP-MS

UV-VIS

IR

Karl Fischer

Particle size analyzer

Dissolution instruments

Job description

Method Validation Research Chemists for Tris Pharma, Inc. to work at our Monmouth Junction, NJ loc.

Perform responsibilities in accordance with company policies, SOPs, + state, federal + local laws. Set up + operate analytical instruments for sample testing (i.e., HPLC, GC, IR, UV/Vis, AA, TLC + Distek/Agilent. Set up + operate analytical instruments for sample testing (i.e., UPLC + ICP- MS. Set up + operate analytical instruments for sample testing (i.e., Karl Fischer, Moisture Balance, Automatic/Manual Titration, Viscosity Meter, Density Meter + Malvern Particle Size Analyzer). Test raw materials (excipients + drug substance) release testing: assay, related substance, particle size distribution, loss on drying, water content, residual ignition, residual solvents, optical rotation, pH, viscosity according to the analytical methods, USP/EP compendial monographs, procedures in a regulated laboratory environment. Perform testing of In-process, drug products and/ or stability samples including assay, blend/ content uniformity, preservatives, related compounds, laser diffraction/ sieve analysis, bulk + tapped density + other tests according to the analytical methods in a GMP env. Perform testing of resin based extended-release Intermediates, resin based extended-release liquid/ solid dosage, form clinical study samples, cleaning verification/ validation methods, qualitative + quantitative analysis to support reference standard qualifications, method comparisons, method validation, verification + transfer. Prepare validation/ verification/ transfer protocols + reports. Perform analytical method interim validation. Analyze samples using appropriate instrumentation such as HPLC, UV, IR, KF, particle size analyzer, pH, etc. Process + report the analysis results using the instrument specific data processing software. Perform calculations associated with test analyses. Label, transcribe + record all testing details + results in laboratory notebooks + report sheets, compliant with current cGDPs, cGMPs + SOPs. Clean, maintain + calibrate laboratory instruments to ensure compliance with cGLPs + cGMPs. Clean + organize MV lab areas. Train + mentor junior chemists on instrument operation + maintenance. Participate in laboratory investigations + root cause determinations. Troubleshoot problems assoc w/ instrumentation, analytical anomalies + laboratory investigations. Track + maintain sample flow. Comply w/ Company policies + procedures, incl but not ltd to safety rules + DEA regulations. Meet project deadlines + performance standards. May undergo background checks incl drug screen. Wage: $113,589 - $127,500 plus comprehensive benefits (A complete list of benefits can be found at trispharma.com/connect/careers).

Requirements

Must have Bachelors in Chemistry or related science field and 5 yrs relevant exp in Method Validation Laboratory under GMP regulation in the pharma industry. Alternatively, must have Masters in Chemistry or related science field and 3 yrs relevant exp in Method Validation Laboratory under GMP regulation in the pharma industry. Any suitable combination of education, training or experience is acceptable.

Required skills: (2 yrs) Spectroscopic and chromatographic techniques and concepts, analytical instrumentation (including: UV-VIS, IR, HPLC, UPLC, GC, ICP-MS, particle size analyzer, and dissolution instruments) in a pharmaceutical manufacturing setting. (5 yrs) of cGMP, FDA, and OSHA regulations and guidances. (3 yrs) Quality systems, including change control systems, analytical testing, calculations and data analysis as instructed for in-process, resin based extended-release liquid/ solid dosage form clinical study samples, drug products and stability samples including assay, blend/ content uniformity, preservatives, related compounds, laser diffraction/ sieve analysis, bulk and tapped density according to the analytical methods in a GMP environment. Performing wet chemistry and physical testing following pharmacopeia monograph of raw materials (excipients and drug substance) release testing including assay, related substance, particle size distribution, loss on drying, water content, residual ignition, residual solvents, optical rotation, pH, viscosity in a regulated laboratory environment. (2 yrs) Performing and interpreting analytical results and laboratory investigations. Cleaning verification/ validation according to the analytical methods in a GMP environment, qualitative and quantitative analysis to support reference standard qualifications, method comparisons, analytical method interim validation, method validation, verification, and transfer. Preparation, validation, verification, transfer protocols and reports. Microsoft Office and Empower software.