QC Compendial Scientist I

QC Compendial Scientist I

Employer: Actalent. Job Title: QC Compendial Scientist I Job Description The QC Compendial Scientist I supports Good Manufacturing Practice (GMP) manufacturing by performing compendial and analytical testing for commercial product release and stability programs. You will work in a cGMP-regulated laboratory, using a variety of analytical tools for large molecule analysis to ensure high-quality data, timely delivery of results, and compliance with established procedures. This entry-level role offers extensive training, ongoing learning, and the opportunity to contribute to new concepts, techniques, and standards in a collaborative and growth-oriented environment. Responsibilities - Perform compendial testing for large molecule analysis, including pH, UV, osmolality, and related methods, on in-process, drug substance (DS) release, and stability samples to support GMP manufacturing and stability programs. - Operate and maintain analytical instruments such as spectrometers, plate readers, SoloVPE, and other minor laboratory equipment to execute routine and specialized test methods. - Conduct GMP testing in an analytical laboratory using HPLC and UPLC test methods, including reverse phase, size-exclusion chromatography (SEC), concentration assays, cation-exchange chromatography (CEX), and related techniques. - Perform colorimetric and other biochemical assays, such as Picogreen and Bradford assays, as required to support analytical testing of large molecules. - Execute qualitative pipetting and, when applicable, multi-channel and 96-well plate pipetting techniques to ensure accurate and precise sample preparation. - Compile and analyze data generated from testing, document test procedures accurately, and prepare clear, concise reports in accordance with laboratory and quality requirements. - Review laboratory data packets as assigned, ensuring completeness, accuracy, and compliance with applicable procedures and regulatory expectations. - Author and perform laboratory inv