Chemist III

Job Purpose

The primary purpose of the job is to perform the testing and decide on the acceptability of the process validation samples, raw materials, finished products, stability samples, and developmental samples in a regulated laboratory environment in support of the timely disposition of manufactured products. Analyze and interpret results in written and oral format.

• Perform routine release tests of raw materials and finished products including wet chemistry analysis, dissolution, content uniformity, assay, particle size distribution, density, water determination by KF, and other tests according to the in‑house specifications and methods and USP monographs using classical wet chemistry and instrumental techniques.
• Perform routine tests such as assays, related compounds, chromatographic purity, residual solvents, particle size distribution, and infrared spectroscopy using different techniques and instrumentation such as UV, HPLC, GC, IR etc.
• Evaluate test results and decide acceptability of the samples based on the results. Review and release raw data, documentation and results for certificates of analysis.
• Write draft technical documents such as specifications, analytical methods, method verification protocols and reports, method transfer documents, investigation reports etc.
• Maintain accurate lab notebooks and complete all related analytical reports, write summaries, and keep proper documentation in compliance with SOPs.
• Follow SOPs and safety guidelines to ensure compliance with a cGMP environment and safety practices. Maintain the laboratory with good housekeeping practices in compliance with cGMP.
• Other duties related to departmental activities may be assigned by management based on situation and necessity.

• Bachelor’s Degree in Chemistry or related scientific field and 2+ years’ industry experience as a Chemist.
• Master’s Degree in Chemistry or related scientific field and 1+ year’s industry experience as a Chemist.
• Knowledge of current GMP guidance, applicable USFDA and ICH guidelines and regulatory requirements (such as USP/ICH requirements).
• Ability to make observations with instruments and analysis techniques.
• Basic knowledge of instrument techniques and software for instruments such as HPLC, GC, IR, KF, Metrohm titrator, etc.
• Ability to carry out necessary computations and to draw and interpret graphs.
• Basic knowledge of method validation, method transfer and method verification of the analytical methods.
• Knowledge of basic to advanced level of computer skills.

Lupin is an equal opportunity and affirmative action employer. All qualified applicants will receive consideration for employment without regard to race, color, national origin, gender, religion, age, disability, veteran’s status, or any other classification as required by applicable law.

The physical requirements of the position generally include standing, walking, sitting, using hands and fingers, reaching with hands and arms, talking and hearing. In some circumstances, bending, kneeling, crouching, stooping, and crawling may apply. This position may require lifting up to 15 pounds occasionally. Work is performed in an office environment.

Collaboration, Customer Centricity, Developing Talent, Innovation & Creativity, Process Excellence, Result Orientation, Stakeholder Management, Strategic Agility

• Medical, Dental, Vision Benefits
• 18 Days of PTO
• 9 Days of Holiday