Method Validation Research Chemist

BioSpace; South Brunswick (NJ); On-site; USD 114,000 - 128,000; Full time

Benefits offered by this job

Comprehensive benefits

Job summary

Tris Pharma, Inc. is seeking a Method Validation Research Chemist to join the Monmouth Junction, NJ team. You will set up and operate analytical instruments (HPLC, GC, IR, UV/Vis, KF, ICP-MS) and perform release testing, validation, and method transfer in a regulated lab.

You will prepare protocols and reports, review data, and help train junior chemists while adhering to cGDPs, cGMPs, and SOPs. A strong background in GMP pharmaceutical method validation is required, with experience in a

Qualifications

• Bachelor's degree in Chemistry or related field with 5+ years GMP pharma method validation experience
• Master's degree in Chemistry or related field with 3+ years GMP pharma method validation experience
• Experience with validation/verification/transfer protocols and reports
• Proficiency with Empower software and analytical data handling
• Strong knowledge of analytical techniques in a regulated GMP lab

Responsibilities

• Set up and operate analytical instruments for sample testing in a GMP lab.
• Perform validation, verification, and transfer activities for analytical methods.
• Prepare validation/verification/transfer protocols and reports.
• Train and mentor junior chemists on instrument operation and data interpretation

Skills

Spectroscopy & Chromatography

cGMP & FDA regulations

Quality systems & data analysis

Analytical method validation & data

Microsoft Office & Empower

Education

Bachelor's degree in Chemistry or related field

Master's degree in Chemistry or related field

Tools

HPLC

GC

ICP-MS

UPLC

UV-Vis

IR

KF

Dissolution

pH meters

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.