Senior Analytical Scientist

PPL Healthcare LLC d/b/a Piramal Pharma Solutions seeks a Senior Analytical Scientist for its Sellersville, PA location.

Duties: Develop, validate, and transfer analytical methods: 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; and Implement Good Laboratory Practices ("GLP") procedures and ensure compliance with U.S. Food and Drug Administration ("USFDA") regulations 21 CFR Part 11. Employ Various Analytical Methods: 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; and operate analytical instruments during raw material, in process, and finished product testing. Review and Analyze Data and Information Related to Product Development and R&D: 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; and analyze trend analytical data where applicable. Perform Initial and Stability Testing: Conduct sample testing to ensure compliance with USFDA and Current Good Manufacturing Practices ("cGMP") requirements according to approved written procedures and specifications; and Perform testing for R&D batches and demonstration batches to support formulation development. Perform Various Functions within Laboratory: 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; and prepare instrument qualification protocols and reports.

Requirements: Master's degree in Chemistry, Pharmacy, Pharmaceutical Sciences, or a closely related field plus 5 years progressive work experience in closely related field. Prior experience must include use of chromatographic HPLC/GC, o X-ray Diffraction (XRD), Malvern particle sizer, Trackwise for QMS, Dissolutions using auto sampler, Infrared spectroscopy, Laboratory Information Management System (LIMS), Solid (tablets/capsules), liquid, and suspension testing experience. Qualified Applicants must send resumes to ... ref: SAS/AM. Direct applicants only.