Senior Analytical Chemist – GMP & Method Development

Great HealthWorks, Inc.; Town of Florida, Northern (NY, KY); Hybrid; USD 90,000 - 130,000; Full time

Job summary

Great HealthWorks, Inc. is seeking a senior Lab Chemist III to lead complex analytical testing for raw materials, in-process materials, stability samples, and finished dietary supplement products. You will develop and validate methods, troubleshoot instruments, and provide training to analysts in a GDP/cGMP environment.

The role emphasizes independent testing, method development, CAPA-led investigations, and data integrity while ensuring adherence to 21 CFR Part 111 and compendial standards.

Qualifications

• Minimum BA/BS in Chemistry or related field.
• 6–10 years in pharma/ dietary supplement GMP labs.
• Experience with HPLC, GC, UV-Vis, FTIR, Karl Fischer, and dissolution.
• Experience with method development, verification, validation, transfer, CAPA.
• Experience in a cGMP regulated analytical laboratory.

Responsibilities

• Perform routine and complex analytical testing using techniques including titration, UV-Vis, FTIR, Karl Fischer, Loss on Drying, Residue on Ignition, dissolution, HPLC, UHPLC/MS, ICP-MS and GC.
• Independently perform analytical testing of raw materials, in-process materials, stability samples, and finished products in accordance with approved specifications, test methods, and applicable compendial requirements.
• Perform method development, verification, validation, optimization, and transfer for analytical test methods.
• Review and evaluate analytical data for accuracy, completeness, and compliance with specifications.
• Assist with OOS/OOT investigations and CAPA development and implementation.
• Train and mentor laboratory analysts on analytical methods and GMP requirements.

Skills

Analytical Chemistry

Lab instrumentation

Data analysis

Communication skills

Attention to detail

Problem solving

Education

Bachelor's degree in Chemistry

Tools

HPLC

GC

UHPLC/MS

Karl Fischer

Dissolution testing

Job description

Great HealthWorks, Inc. is seeking a senior Lab Chemist III to lead complex analytical testing for raw materials, in-process materials, stability samples, and finished dietary supplement products. You will develop and validate methods, troubleshoot instruments, and provide training to analysts in a GDP/cGMP environment.

The role emphasizes independent testing, method development, CAPA-led investigations, and data integrity while ensuring adherence to 21 CFR Part 111 and compendial standards.