Granules Pharmaceuticals, Inc.
Analytical Chemist II /Bio-Chemist (Pharmaceutical Manufacturing)
Granules Pharmaceuticals, Inc., Chantilly, Virginia, United States, 22021
Analytical Chemist II /Bio-Chemist (Pharmaceutical Manufacturing)
Join to apply for the Analytical Chemist II /Bio-Chemist (Pharmaceutical Manufacturing) role at Granules Pharmaceuticals, Inc.
Description
Granules Pharmaceuticals Inc. (GPI) is a subsidiary of Granules India LTD. Over the past 34 years, GPI has grown to become the 10th fastest‑growing generic pharma company in the US, with R&D and manufacturing sites in Chantilly and Manassas, Virginia. The company focuses on the manufacturing, packaging, and testing of generic drugs, including pulsatile drug release, orally disintegrating tables, modified‑release tablets, and controlled‑substance formulations.
Job Summary As a QC Biochemist/Analytical Chemist II, you will support manufacturing and R&D operations by performing routine and non‑routine analytical testing of raw materials, in‑process samples, finished products, and stability samples. In addition, you will conduct method development, method transfer, and instrument qualification activities to ensure compliance with cGMP and company procedures.
Job Duties & Responsibilities
Conduct routine analytical/microbiological testing of raw materials, packaging materials, finished product release, and stability using approved methods and instrumentation while adhering to cGMP and established policies.
Perform analytical USP method verifications, validations, and method transfer activities for raw materials and finished dosage forms.
Calibrate, qualify, maintain, and troubleshoot analytical instruments such as UPLC, HPLC, GC, UV spectrophotometer, dissolution apparatus, KF auto‑titrator, FT‑IR, polarimeter, and refractometer.
Compile laboratory test data and perform analyses, including physical (solubility, viscosity), chemical (titration), and analytical (FTIR, HPLC, ICP‑MS, UV‑Vis, KF, IC) testing.
Document testing procedures, maintain test forms and logbooks, and interpret results to ensure compliance with specifications and release criteria.
Participate in out‑of‑specification investigations and support all aspects of laboratory investigations.
Prepare, review, and approve analytical data, technical reports, and analytical methods.
Coordinate microbiological, preservative efficacy, and antimicrobial testing per USP/USP‑NF for active and inactive ingredients, finished products, and stability samples for regulatory filings.
Physical Requirements / Working Environment
Lift up to 40 pounds, frequently walk through the plant or warehouse.
Commit to long work hours when necessary to meet goals.
Use respirator, lab coat, safety glasses, and glove‑box for handling potent substances.
This Job Is Ideal For Someone Who Is
Dependable and reliable.
People‑oriented and enjoys group projects.
Adaptable and flexible to frequent changes.
Detail‑oriented, focusing on precision.
Achievement‑oriented and embraces challenges.
Autonomous and can work independently.
Innovative and creative.
High stress tolerance in a high‑pressure environment.
Preferred Knowledge & Skills
Strong knowledge of HPLC/UPLC, GC, dissolution, FT‑IR, and FDA/ICH regulations.
Solid understanding of FDA/ICH regulatory requirements.
Required Experience & Education
BS or MS in Chemistry, Pharmacy, Biochemistry, Biology, Biotechnology, or related field.
2–5 years of experience with analytical instrumentation (HPLC/GC/FT‑IR, UV‑Vis, dissolution apparatus, auto‑titrators, KF, particle size analyzers, ion chromatography).
Seniority Level Mid‑Senior level
Employment Type Full‑time
Job Function Research, Analyst, Information Technology
Industries Pharmaceutical Manufacturing
Location Chantilly, VA (and nearby areas)
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Description
Granules Pharmaceuticals Inc. (GPI) is a subsidiary of Granules India LTD. Over the past 34 years, GPI has grown to become the 10th fastest‑growing generic pharma company in the US, with R&D and manufacturing sites in Chantilly and Manassas, Virginia. The company focuses on the manufacturing, packaging, and testing of generic drugs, including pulsatile drug release, orally disintegrating tables, modified‑release tablets, and controlled‑substance formulations.
Job Summary As a QC Biochemist/Analytical Chemist II, you will support manufacturing and R&D operations by performing routine and non‑routine analytical testing of raw materials, in‑process samples, finished products, and stability samples. In addition, you will conduct method development, method transfer, and instrument qualification activities to ensure compliance with cGMP and company procedures.
Job Duties & Responsibilities
Conduct routine analytical/microbiological testing of raw materials, packaging materials, finished product release, and stability using approved methods and instrumentation while adhering to cGMP and established policies.
Perform analytical USP method verifications, validations, and method transfer activities for raw materials and finished dosage forms.
Calibrate, qualify, maintain, and troubleshoot analytical instruments such as UPLC, HPLC, GC, UV spectrophotometer, dissolution apparatus, KF auto‑titrator, FT‑IR, polarimeter, and refractometer.
Compile laboratory test data and perform analyses, including physical (solubility, viscosity), chemical (titration), and analytical (FTIR, HPLC, ICP‑MS, UV‑Vis, KF, IC) testing.
Document testing procedures, maintain test forms and logbooks, and interpret results to ensure compliance with specifications and release criteria.
Participate in out‑of‑specification investigations and support all aspects of laboratory investigations.
Prepare, review, and approve analytical data, technical reports, and analytical methods.
Coordinate microbiological, preservative efficacy, and antimicrobial testing per USP/USP‑NF for active and inactive ingredients, finished products, and stability samples for regulatory filings.
Physical Requirements / Working Environment
Lift up to 40 pounds, frequently walk through the plant or warehouse.
Commit to long work hours when necessary to meet goals.
Use respirator, lab coat, safety glasses, and glove‑box for handling potent substances.
This Job Is Ideal For Someone Who Is
Dependable and reliable.
People‑oriented and enjoys group projects.
Adaptable and flexible to frequent changes.
Detail‑oriented, focusing on precision.
Achievement‑oriented and embraces challenges.
Autonomous and can work independently.
Innovative and creative.
High stress tolerance in a high‑pressure environment.
Preferred Knowledge & Skills
Strong knowledge of HPLC/UPLC, GC, dissolution, FT‑IR, and FDA/ICH regulations.
Solid understanding of FDA/ICH regulatory requirements.
Required Experience & Education
BS or MS in Chemistry, Pharmacy, Biochemistry, Biology, Biotechnology, or related field.
2–5 years of experience with analytical instrumentation (HPLC/GC/FT‑IR, UV‑Vis, dissolution apparatus, auto‑titrators, KF, particle size analyzers, ion chromatography).
Seniority Level Mid‑Senior level
Employment Type Full‑time
Job Function Research, Analyst, Information Technology
Industries Pharmaceutical Manufacturing
Location Chantilly, VA (and nearby areas)
#J-18808-Ljbffr