AR&D Chemist: Analytical Method Validation & Drug Development

KVK Tech, Inc.; Pennsylvania; On-site; USD 85,000 - 110,000; Full time

Benefits offered by this job

401(k) with company match

Health, vision, and dental Insurance

Annual merit increases

Paid Time Off and Flexible Holidays

Job summary

KVK Tech, Inc. in Newtown, PA is seeking an AR&D Chemist to develop and validate analytical methods for raw materials, APIs, and finished drug products.

The role ensures FDA compliance using HPLC/UPLC, SOPs, GC, and UV spectrophotometric methods. You will support drug development from discovery through commercial launch, including stability studies and impurity profiling, and will execute validation and cleaning validation protocols while calibrating and maintaining instruments in a cGMP

Qualifications

• Master’s degree in Chemistry, Pharmaceutical Science, or Pharmacy required.
• Experience with cGMP, CAPA, APQR, and QMS preferred.
• Proficiency with HPLC/UPLC, SOPs, APQR, and CAPA processes.
• Experience in analytical method validation and cleaning validation.

Responsibilities

• Develop and validate analytical methods for raw materials, APIs, and finished drugs.
• Ensure compliance with FDA regulations using HPLC/UPLC, GC, UV spectrophotometer, and other instruments.
• Support drug development from discovery through commercial launch, including stability studies and impurity profiling.
• Execute and review analytical method validation and cleaning validation protocols and reports.
• Calibrate and maintain laboratory instruments.

Skills

HPLC/UPLC

SOP compliance

GC

UV spectrophotometry

Dissolution testing

KF Autotitrator

Chemstation

Class-VP

Spectrophotometer

Polarimeter

Refractometer

Mass spectrometry

Laser Diffraction

Education

Master’s degree in Chemistry/Pharmaceutical Science/Pharmacy

Tools

Chemstation

Class-VP

Spectrophotometer

Polarimeter

Refractometer

Mass spectrometry

Laser Diffraction (LD) Particle Size analyzer

HPLC/UPLC systems

KF Autotitrator

Job description

KVK Tech, Inc. in Newtown, PA is seeking an AR&D Chemist to develop and validate analytical methods for raw materials, APIs, and finished drug products.

The role ensures FDA compliance using HPLC/UPLC, SOPs, GC, and UV spectrophotometric methods. You will support drug development from discovery through commercial launch, including stability studies and impurity profiling, and will execute validation and cleaning validation protocols while calibrating and maintaining instruments in a cGMP