Scientist I

Responsibilities: of the Scientist I: • Perform hands-on analytical sample preparation and extraction of target analytes from complex raw material and finished-product matrices utilizing dilution, filtration, centrifugation, and multi-step extraction techniques. • Evaluate extraction efficiency, sample recovery, dilution requirements, and matrix interference while supporting method verification and validation studies. • Author, execute, and summarize method verification and validation protocols and reports in accordance with USP <1225>, USP <1226>, and ICH Q2(R2) guidelines. • Conduct HPLC analysis utilizing Empower chromatography software to generate, review, and report analytical data while troubleshooting sample preparation and analytical issues. • Maintain complete cGMP documentation including lab notebooks, data review, protocol execution, and adherence to approved SOPs and data integrity requirements. • Support analytical testing of raw materials, in-process samples, and finished products while participating in method transfers and lab investigations as needed. Qualifications: of the Scientist I: • BS or MS in Chemistry or related scientific discipline with 4+ years of pharmaceutical laboratory experience. • Extensive hands-on experience with analytical sample preparation, extraction procedures, recovery studies, and troubleshooting matrix-related analytical challenges. • Proven experience performing and documenting method verifications, method validations, and method transfers within a cGMP environment. • Advanced proficiency with HPLC chromatography and Empower software; experience with Agilent HPLC systems is preferred. • Strong understanding of FDA-regulated laboratory operations, cGMP requirements, and data integrity principles. • Comprehensive knowledge of USP <1225>, USP <1226>, ICH Q2(R2), and pharmaceutical analytical testing requirements.