Analytical Scientist / Senior Analytical Scientist

RK PHARMA INC • East Windsor Township, NJ

7h • $70,000 - $90,000

About The Position

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.

Requirements

• Bachelor's degree in Chemistry, Analytical Chemistry, Pharmaceutical Sciences, Pharmacy, or a related scientific discipline.
• 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.
• Strong working knowledge of HPLC, UPLC, and GC systems
• Strong working knowledge of UV-Visible Spectrophotometer
• Strong working knowledge of FTIR Spectroscopy
• Strong working knowledge of Dissolution Testing (USP Apparatus I & II)
• Strong working knowledge of Particle Size Analysis (Malvern Mastersizer and Zetasizer)
• Strong working knowledge of Karl Fischer Titration
• Strong working knowledge of Brookfield Viscometer
• Strong working knowledge of Empower 3
• Strong working knowledge of LabSolutions
• Strong working knowledge of SAP
• Strong working knowledge of Microsoft Office Suite
• Strong working knowledge of FDA Regulations
• Strong working knowledge of ICH Guidelines
• Strong working knowledge of USP Requirements
• Strong working knowledge of cGMP
• Strong working knowledge of cGLP
• Strong working knowledge of GDP
• Strong working knowledge of Quality by Design (QbD)

Nice To Haves

• Master's degree preferred.
• Experience supporting injectable, or oral liquid products 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 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.

Benefits

• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level