Senior Analytical Scientist - Pharma Method Validation

RK Pharma

Pearl River (NY)

On-site

USD 90,000 - 120,000

Full time

9 days ago

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Job summary

RK Pharma in Pearl River, NY is seeking an Analytical Scientist/Senior Analytical Scientist to lead analytical development, validation, testing, and lifecycle activities across pharmaceutical programs. You will collaborate with Regulatory Affairs, QA, Manufacturing, and Development to ensure compliant data and methods.

The role requires a strong analytical mindset, 5+ years in pharma labs (8–12+ for senior), and hands-on experience with HPLC/UPLC/GC, dissolution, and QC procedures.

Qualifications

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

Responsibilities

  • Develop, optimize, 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 instrumentation.
  • 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 Affairs, Quality Assurance, Manufacturing, and Development teams.
  • Mentor junior analysts and support training activities where appropriate.

Skills

Analytical mindset
Team collaboration

Education

Bachelor's degree in Chemistry / Analytical Chemistry / Pharmaceutical Sciences / Pharmacy
Master's degree preferred

Tools

Empower 3
LabSolutions
SAP
Microsoft Office

Job description

RK Pharma in Pearl River, NY is seeking an Analytical Scientist/Senior Analytical Scientist to lead analytical development, validation, testing, and lifecycle activities across pharmaceutical programs. You will collaborate with Regulatory Affairs, QA, Manufacturing, and Development to ensure compliant data and methods.

The role requires a strong analytical mindset, 5+ years in pharma labs (8–12+ for senior), and hands-on experience with HPLC/UPLC/GC, dissolution, and QC procedures.

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