Senior Analytical Scientist: Method Development & QC Lead

Socket.dev; East Windsor Township (NJ); On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

Stable work environment

Clear expectations

Procedural training

Quality-focused culture

Job summary

RK Pharma is seeking an Analytical Scientist to support development, validation, and lifecycle activities across pharmaceutical programs. The role collaborates with Formulation Development, Quality Assurance, Regulatory Affairs, Manufacturing, and Quality Control to ensure data and methods meet regulatory expectations.

The hire level will be based on experience, with responsibilities spanning method development, transfer, testing, and documentation in a fast-moving, compliant environment.

Qualifications

• Bachelor's degree in Chemistry, Analytical Chemistry, Pharmaceutical Sciences, Pharmacy, or related field; Master’s preferred.
• Analytical Scientist: 5+ years; Senior: 8–12+ years in pharmaceutical lab analytics.
• Experience with injectable or oral liquid products 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 Spectroscopy, FTIR, dissolution systems, and particle size analysis instrumentation.
• Execute and monitor stability studies; prepare and review SOPs, specifications, protocols, reports, and documentation.
• Support investigations involving OOS, OOT, deviations, CAPAs, and change controls.
• Operate, maintain, calibrate, and troubleshoot laboratory instrumentation.
• Collaborate with Regulatory Affairs, QA, Manufacturing, and Development teams.
• Mentor junior analysts and support training activities.

Skills

Analytical development

Quality control

Regulatory compliance

Cross-functional collaboration

Education

Bachelor's degree in Chemistry

Master's degree preferred

Tools

HPLC/UPLC

GC

UV-Vis

FTIR

Dissolution

Particle Size

Karl Fischer

Brookfield Viscometer

Empower 3

LabSolutions

SAP

MS Office

Job description

RK Pharma is seeking an Analytical Scientist to support development, validation, and lifecycle activities across pharmaceutical programs. The role collaborates with Formulation Development, Quality Assurance, Regulatory Affairs, Manufacturing, and Quality Control to ensure data and methods meet regulatory expectations.

The hire level will be based on experience, with responsibilities spanning method development, transfer, testing, and documentation in a fast-moving, compliant environment.