Analytical & Method Development Chemist

Job Description Summary

Develop and validate analytical methods, evaluate instrumentation, and support quality control and product testing.

The Analytical Chemist evaluates new testing applications and instrumentation. They develop or adopt compendial methods and help transfer them into quality control for routine use. Additionally, the Chemist assists Operations, Sales, and Quality in preparing and testing samples for current and prospective customers.

• Liaison between Quality Control, Product Development, and Contract laboratories by evaluating and assessing testing methodologies and applying them to different sample matrices, including evaluating test results from contract laboratories to ensure correct methods and testing parameters were followed.
• Help with routine and non‑routine sample testing in the QC laboratory and evaluate testing feasibility of new samples before sending them to contract laboratories.
• Work with stability program personnel to monitor new product behavior during stability studies.
• Evaluate new testing applications, calibrate instrumentation, develop or adopt compendial methods, and transfer new methods into QC for routine use, ensuring accuracy, precision, and robustness.
• Assist in resolving OOS results in the analytical laboratory, ensuring proper instrument use and that no malfunctions or product formulation interferences cause OOS results.
• Assist in training new laboratory personnel, with documentation per SOPs.
• Follow cGMP documentation guidelines to record procedures in a timely fashion, maintain a safe working environment, and ensure equipment calibration and proper maintenance.
• Apply chemical theory and analytical instrumentation knowledge (HPLC, GC, ICP‑MS, ICP‑OES, etc.).
• Handle specific projects and perform other functions required to meet company objectives.

• Bachelor’s, Master’s, or PhD in Chemistry, Biochemistry, or applied science, with experience in quality organizations in food, pharmaceutical, chemical, or chemistry labs.
• Demonstrated ability to work with diverse teams and strong communication skills.
• Strong organizational, analytical, and leadership skills.
• Ability to research USP, FDA, and other regulatory bodies to ensure compliance in QA/QC chemistry laboratories.
• Exceptional computer and spreadsheet skills.
• Ability to troubleshoot equipment.
• Physical requirements:
  
  able to walk, kneel, climb stairs, lift 25–50 lbs, and work a flexible schedule including weekends.
• Three to five years’ experience in food and drug GMPs preferred.