Pharmaceutical Analytical Method Developer | cGMP

Automatic Data Processing, Inc.; Mount Laurel Township (NJ); On-site; USD 72,000 - 88,000; Full time

Benefits offered by this job

Medical insurance

Dental & Vision

401K match

Bonus program

Paid time off

Job summary

Stokes Healthcare in Mount Laurel, NJ is seeking a Method Development Scientist to oversee development and validation of analytical methods for pharmaceutical products. You will ensure data credibility, conduct experiments, and document findings to support regulatory compliance.

The role requires a strong background in HPLC/UPLC/GC, Empower 3, and GLP/GxP practices, with leadership responsibilities including mentoring junior scientists and collaborating across functions to advance projects.

Qualifications

• Bachelor's in Chemistry or related field.
• Minimum 5 years in pharma analytical testing.
• Knowledge of HPLC/UPLC/GC and Empower 3 software.
• Proficiency in statistics and experimental design.
• Strong documentation and regulatory writing skills.

Responsibilities

• Develop and optimize analytical methods for pharmaceutical compounds.
• Stay updated with latest analytical techniques and technologies.
• Collaborate with cross-functional teams to support development projects.
• Lead and mentor junior scientists and provide technical guidance.
• Ensure testing is performed per cGMP, USP, ICH and FDA standards.
• Author and revise SOPs, protocols and data reports.
• Lead equipment qualification and calibration activities.
• Adhere to laboratory safety and regulatory standards.

Skills

Analytical method development

HPLC/UPLC/GC

Empower 3 software

Statistical analysis

Regulatory compliance

SOP writing

GxP knowledge

Lab instrumentation

Education

Bachelor's in Chemistry or related field

Tools

Karl Fischer titrator

pH meter

Analytical balance

Micropipettes

Centrifuge

Job description

Stokes Healthcare in Mount Laurel, NJ is seeking a Method Development Scientist to oversee development and validation of analytical methods for pharmaceutical products. You will ensure data credibility, conduct experiments, and document findings to support regulatory compliance.

The role requires a strong background in HPLC/UPLC/GC, Empower 3, and GLP/GxP practices, with leadership responsibilities including mentoring junior scientists and collaborating across functions to advance projects.