Analytical Chemist II / Bio-Chemist

1d1 day ago

Granules India Limited

Chantilly, US · Full-time · $80,000 – $105,000

About this role

Granules Pharmaceuticals Inc., a subsidiary of Granules India LTD, is the 10th fastest growing generic pharma company in the US after 34 years. Sites in Chantilly and Manassas, Virginia, cover R&D through manufacturing and packaging of pulsatile drug release tablets, orally disintegrating modified release tablets, suspensions, and abuse-deterrent controlled substances.

The QC Biochemist/Analytical Chemist II supports operations and manufacturing by performing routine and non-routine analytical testing on raw materials, in-process, finished formulations, stability samples, method development, transfers, and cleaning validations. Follows standard procedures that vary in scope, sequence, complexity, and timing while ensuring safe and efficient execution.

Conducts testing using approved methods and instrumentation like UPLC, HPLC, GC, UV, dissolution apparatus, KF titrator, FT-IR, polarimeter, adhering to cGMP and policies. Compiles data from physical, chemical, and analytical tests, interprets results against specifications, and participates in out-of-specification investigations.

Multiple positions available in QC and R&D within a dedicated team focused on excellence in manufacturing, quality, and commercialization of generic drugs. Works in an environment requiring respirator, lab coat, safety glasses, and handling potent substances in glove-boxes.

Requirements

Proficiency in analytical techniques including HPLC, UPLC, GC, UV-Vis, FTIR, KF, ICP-MS, IC
Experience with USP method verifications, validations, and transfers for raw materials and finished dosage forms
Knowledge of cGMP, laboratory documentation, and data integrity practices
Ability to calibrate, qualify, maintain, and troubleshoot analytical instruments
Skill in interpreting analytical test results against specifications and control limits
Experience participating in OOS and laboratory failure investigations
Ability to lift 40 pounds, walk across plant/warehouse, and commit to long hours when necessary
Capability to work with potent substances using respirator, lab coat, safety glasses, and glove-box

Responsibilities

Conduct routine analytical/microbiological testing of raw materials, packaging materials, finished product release and stability using approved methods and various instrumentation while adhering to cGMP
Conduct analytical USP method verifications, validations, and method transfer activities for raw materials and finished dosage forms
Perform the Calibration, Qualification, Preventive maintenance and routine trouble shooting of analytical instruments like UPLC, HPLC, GC, UV spectrophotometer, Dissolution apparatus, KF Auto titrator, FT-IRS spectrophotometer, Polarimeter and Refractometer
Compile laboratory test data and perform appropriate analyses that include physical, chemical and analytical testing
Complete documentation needed to support testing procedures including test forms and logbooks
Interpret test results, compare them to established specifications and control limits, and ensure appropriateness of data for release
Participate in out-of-specification and failure investigations and support all aspects of laboratory investigations
Coordinate Microbiological, preservative efficacy/antimicrobial effectiveness testing as per USP/USP-NF for APIs, excipients, finished products and stability samples