Senior Analytical Chemist, Pharmaceutical Method Development

Lannett Company

Seymour, Northern (IN, KY)

Hybrid

USD 65,000 - 90,000

Full time

14 days+

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Job summary

Lannett Company is seeking a qualified analytical chemist to perform laboratory testing of raw materials, APIs, in-process and finished products. The role includes method development and validation in line with ICH/FDA/USP requirements, and performance of routine and non-routine analyses using HPLC, GC, dissolution, and related techniques.

Candidates should have a BS in Chemistry or related field with 4–8 years of pharmaceutical analysis in a cGMP-regulated lab.

Qualifications

BS Degree in Chemistry or related field; 4–8 years pharmaceutical analysis in a cGMP lab.
Experience in pharmaceutical industry or analytical lab.
Knowledge of cGMP, USP/NF, FDA guidelines.
Expertise in analytical methods and lab instrumentation (HPLC, GC, dissolution).
Ability to perform method development and validation with minimal supervision.
Excellent oral and written communication skills.

Responsibilities

Perform routine and non-routine tests on raw materials, APIs, in-process, finished products, and stability samples.
Conduct analyses using pH, Loss on Drying, Karl Fischer, HPLC, GC, dissolution, etc.
Develop analytical methods to test products per ICH/FDA/USP requirements.
Validate test methods for assay, dissolution, residual solvents and impurities.
Document all laboratory testing with accurate notebooks and records.
Train and mentor team members on analytical instrumentation and methods.