Job Information
Piramal Pharma Solutions Senior Analytical Scientist in Sellersville, Pennsylvania
PPL Healthcare LLC d/b/a Piramal Pharma Solutions seeks a Senior Analytical Scientist for its Sellersville, PA location.
Duties: Design and perform method validation studies to support testing of raw materials, in process, finished products, and stability samples of test batches. Develop and validate dissolution, assay, related substances, and forced degradation analytical methods utilizing various chromatography techniques such as liquid chromatographymass spectrometry ("LC/MS"), Dissolution, high speed liquid chromatography ("HPLC") & gas chromatography ("GC"). Evaluate and select proper assay procedures and conduct analyses of chemical compositions of raw materials, manufactured products, and various samples using HPLC and GC. Perform the method transfer for Particle size testing using Malvern analyzer. Establish proper documentation practices. Issue validation protocols and reports. Conduct analytical method transfers to quality control labs. Implement Good Laboratory Practices ("GLP") procedures and ensure compliance with U.S. Food and Drug Administration ("USFDA") regulations 21 CFR Part 11. Use analytical methods such as cleaning verification, assay and related substances, dissolution, residual solvents in-process control, and analyses of finished products and excipients. Perform physical and chemical analyses of various substances and prepare standards as per requirement. Operate analytical instruments during raw material, in process, and finished product testing. Compile data results in accordance with standard operating procedures ("SOPs") and quality control ("QC") best practices. Perform detailed review of analytical test results data to ensure technical correctness, accuracy, and precision. Analyze trend analytical data where applicable. Conduct sample testing to ensure compliance with USFDA and Current Good Manufacturing Practices ("cGMP") requirements according to approved written procedures and specifications. Perform testing for R&D batches and demonstration batches to support formulation development. Employ GLP procedures to maintain laboratory equipment. Execute laboratory instrumentation qualification, preventative maintenance, calibration, and minor repairs. Calibrate analytical instruments. Maintain proper documentation and logbooks related to maintenance and repairs. Prepare instrument qualification protocols and reports.
Requirements: Must possess a Bachelor's degree in Chemistry, Pharmacy, Pharmaceutical Sciences, or a closely related field plus five (5) years of progressive post-baccalaureate experience as an analytical scientist or a closely related occupation. Prior experience must include: The use of chromatographic HPLC/GC; X-ray Diffraction (XRD); Malvern particle sizer; Trackwise for QMS; Dissolutions using auto sampler; Infrared spectroscopy; LIMS (laboratory information management system); Solid (tablets/capsules), liquid, and suspension testing experience. Full-time. Direct applicants only.