Analytical Scientist / Senior Analytical Scientist

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

Description

About RK Pharma

RK Pharma is a pharmaceutical organization focused on developing and manufacturing high-quality, affordable drug products through disciplined execution and strong internal collaboration. Our teams work across development, quality, manufacturing, and regulatory functions to bring products from concept to commercialization while maintaining the standards expected in regulated pharmaceutical environments. We value people who are thoughtful, scientifically curious, and committed to doing careful work.

About the Role

The Analytical Scientist / Senior Analytical Scientist supports analytical development, validation, testing, and product lifecycle activities across a variety of pharmaceutical programs. This role works closely with Formulation Development, Quality Assurance, Regulatory Affairs, Manufacturing, and Quality Control to ensure analytical methods and laboratory data meet scientific and regulatory expectations. The level of hire will be based on experience and demonstrated expertise.

Key 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 Spectroscopy, FTIR, dissolution systems, and particle size analysis instrumentation. Support formulation and development projects through analytical testing and scientific collaboration.
• Execute and monitor stability studies. 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.

What We’re Looking For

Required

• Bachelor's degree in Chemistry, Analytical Chemistry, Pharmaceutical Sciences, Pharmacy, or a related scientific discipline. Master's degree preferred.
• Analytical Scientist: approximately 5+ years of pharmaceutical laboratory experience. Senior Analytical Scientist: approximately 8–12+ years of pharmaceutical analytical development and/or quality control experience.
• Experience supporting injectable, or oral liquid products preferred.

Technical Expertise

Strong working knowledge of :

Instrumentation

• HPLC, UPLC, and GC systems
• UV-Visible Spectrophotometer
• FTIR Spectroscopy
• Dissolution Testing (USP Apparatus I & II)
• Particle Size Analysis (Malvern Mastersizer and Zetasizer)
• Karl Fischer Titration
• Brookfield Viscometer

Software

• Empower 3
• LabSolutions
• SAP
• Microsoft Office Suite

Regulatory Knowledge

• FDA Regulations
• ICH Guidelines
• USP Requirements
• cGMP
• cGLP
• GDP
• Quality by Design (QbD)

How We Work

At RK Pharma, quality comes before speed. We believe strong science is built through curiosity, collaboration, and disciplined execution. People who succeed here tend to be thoughtful, dependable, scientifically curious, accountable, and comfortable working across teams.

People who succeed in this role are steady, reliable, and take pride in supporting the environment where quality work happens.

What We Offer

• A stable and respectful work environment
• Clear expectations and consistent routines
• Training on procedures and safety requirements
• The opportunity to contribute to a workplace that depends on cleanliness and care

Equal Opportunity Employer

RK Pharma is an equal opportunity employer. We are committed to fair, consistent, and respectful hiring practices.