Analytical Chemist II / Bio-Chemist

1w1 week ago

Granules India Limited

Chantilly, US · Full-time · $75,000 – $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 over the past 34 years. 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, and cleaning validations. Multiple positions are available in QC and R&D.

Conduct routine analytical and microbiological testing of raw materials, packaging, finished products, and stability samples using approved methods and instrumentation while adhering to cGMP. Perform USP method verifications, validations, transfers, instrument calibrations, qualifications, preventive maintenance, and troubleshooting for UPLC, HPLC, GC, UV, dissolution apparatus, and more. Compile test data for physical, chemical, and analytical testing including solubility, viscosity, titration, FTIR, ICP-MS.

Work across sites in Chantilly and Manassas, Virginia, with capabilities in pulsatile drug release, modified release tablets, suspensions, and abuse-deterrent controlled substances. Physical requirements include lifting 40 pounds, walking across plant/warehouse, using respirator, lab coat, safety glasses, and glove-box for potent substances. Commitment to long hours when necessary to achieve goals.

Interpret test results against specifications, ensure data integrity, participate in OOS and failure investigations, prepare technical reports and methods. Coordinate microbiological and preservative efficacy testing per USP for APIs, excipients, finished products, and stability for regulatory filings. Ideal for dependable, people-oriented, adaptable, detail-oriented professionals.

Requirements

Proficiency in analytical instrumentation including UPLC, HPLC, GC, UV spectrophotometer, Dissolution apparatus, KF titrator, FT-IR, Polarimeter, Refractometer
Experience conducting USP method verifications, validations, and transfers for raw materials and finished dosage forms
Knowledge of cGMP practices and established policies for laboratory testing
Ability to perform physical, chemical, and instrumental analyses such as solubility, viscosity, titration, FTIR, ICP-MS, UV-Vis, KF, IC
Skills in laboratory documentation, data integrity, and interpretation against specifications
Familiarity with out-of-specification investigations and laboratory troubleshooting
Capability to handle microbiological and preservative efficacy testing per USP-NF

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 calibration, qualification, preventive maintenance and routine troubleshooting of analytical instruments like UPLC, HPLC, GC, UV spectrophotometer, Dissolution apparatus, KF Auto titrator, FT-IR spectrophotometer, Polarimeter and Refractometer
Compile laboratory test data and perform appropriate analyses including physical (solubility, viscosity), chemical (titration) and analytical (FTIR, HPLC, ICP-MS, UV-Vis, KF, IC) 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 with high integrity
Participate in out-of-specification and failure investigations and support all aspects of laboratory investigations
Prepare, review and approve analytical data, technical reports and analytical methods

Benefits

Multiple positions available in QC and R&D
Part of the 10th fastest growing generic pharma company in the US
Dedicated to excellence in manufacturing, quality, and commercialization of generic drugs