Senior Analytical Scientist – Pharma Method Development

RK Pharma; New Jersey; On-site; USD 85,000 - 120,000; Full time

Job summary

RK Pharma is seeking an Analytical Scientist to advance analytical development, validation, testing, and lifecycle activities across pharmaceutical programs. You will work with Formulation Development, Quality Assurance, Regulatory Affairs, Manufacturing, and Quality Control to ensure analytical methods meet scientific and regulatory expectations.

The role requires a Bachelor’s in Chemistry or related field (Master’s preferred) and 5+ years in pharma labs for Scientist, or 8–12+ years for Senior

Qualifications

• Bachelor's degree in Chemistry, Analytical Chemistry, Pharmaceutical Sciences, Pharmacy, or related discipline. Master's preferred.
• Analytical Scientist: ~5+ years of pharma lab experience; Senior: ~8–12+ years in analytical development/QA.
• Experience with injectable or oral liquid products is preferred.

Responsibilities

• Develop, validate, and transfer analytical methods for assay, related substances, dissolution, cleaning validation, and stability testing.
• Support method verification, transfers, and lifecycle management.
• Perform analytical testing of APIs, raw materials, in-process samples, finished products, and stability samples.
• Execute testing using HPLC, UPLC, GC, UV-Visible, FTIR, dissolution systems, and particle size analysis; support projects.
• Prepare and review SOPs, specifications, protocols, reports, and laboratory documentation.
• Support investigations involving OOS, OOT, deviations, CAPAs, and change controls.
• Operate, maintain, calibrate, and troubleshoot laboratory instrumentation.
• Collaborate with Regulatory, QA, Manufacturing, and Development teams.
• Mentor junior analysts and support training.

Skills

Analytical Method Development

Method Transfer

HPLC/UPLC/GC

Regulatory Knowledge

OOS/OOT Investigation

Education

Bachelor's in Chemistry/Pharmaceutical Sciences

Master's degree preferred

Tools

Empower 3

LabSolutions

SAP

Microsoft Office

Job description

RK Pharma is seeking an Analytical Scientist to advance analytical development, validation, testing, and lifecycle activities across pharmaceutical programs. You will work with Formulation Development, Quality Assurance, Regulatory Affairs, Manufacturing, and Quality Control to ensure analytical methods meet scientific and regulatory expectations.

The role requires a Bachelor’s in Chemistry or related field (Master’s preferred) and 5+ years in pharma labs for Scientist, or 8–12+ years for Senior