Pharma Method Validation Scientist (GMP)

Tris Pharma, Inc.; New Jersey; Sur place; USD 114 000 - 128 000; Plein temps

Résumé du poste

Tris Pharma, Inc. in Monmouth Junction, NJ is seeking Method Validation Research Chemists to join our GMP-compliant labs. You will set up and operate analytical instruments (HPLC, GC, UV/Vis, IR, KF, ICP-MS), test raw materials and in-process samples, and prepare validation and transfer reports.

You will contribute to method validation, troubleshooting, and investigations while mentoring junior chemists and ensuring compliance with cGDPs and cGMPs. This role offers comprehensive benefits.

Qualifications

• Bachelor's degree in Chemistry or related science with 5 years of GMP method validation experience.
• Master's degree in Chemistry or related science with 3 years of GMP method validation experience.
• Any suitable combination of education, training or experience is acceptable.
• 2 yrs of spectroscopic and chromatographic techniques and concepts in a pharmaceutical manufacturing setting.
• Familiar with cGMP, FDA, and OSHA regulations.
• Experience with quality systems, change control, data analysis, and method validation transfer.

Responsabilités

• Set up and operate analytical instruments for sample testing (HPLC, GC, UV/Vis, IR, KF, ICP-MS).
• Test raw materials, in-process, drug products, and stability samples per USP/EP where applicable.
• Prepare validation, verification, transfer protocols and reports; perform interim validation.
• Analyze samples and report results using instrument software; perform calculations.
• Troubleshoot instrumentation and participate in investigations; track sample flow.
• Train and mentor junior chemists; ensure compliance with cGDPs and cGMPs.

Connaissances

Spectroscopic and chromatographic tech

Analytical instrumentation

cGMP FDA OSHA regulations

Quality systems and validation

Laboratory investigations

Empower software

Microsoft Office

Formation

Bachelor's degree in Chemistry or related science

Master's degree in Chemistry or related science

Outils

HPLC

UPLC

GC

ICP-MS

UV-Vis

IR

KF

Particle size analyzer

Dissolution instruments

Description du poste

Tris Pharma, Inc. in Monmouth Junction, NJ is seeking Method Validation Research Chemists to join our GMP-compliant labs. You will set up and operate analytical instruments (HPLC, GC, UV/Vis, IR, KF, ICP-MS), test raw materials and in-process samples, and prepare validation and transfer reports.

You will contribute to method validation, troubleshooting, and investigations while mentoring junior chemists and ensuring compliance with cGDPs and cGMPs. This role offers comprehensive benefits.