Analytical Scientist

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

Duties: Develop, Validate, and Transfer Analytical Methods for Solid and Liquid Oral Dosages: Assist with method validation studies to support testing of raw materials, in process, finished products, and stability samples of test batches; Validate dissolution, assay, related substances, and forced degradation analytical methods utilizing various chromatography techniques such as liquid chromatography-mass

spectrometry ("LC/MS"), Dissolution, high speed liquid chromatography ("HPLC") & gas chromatography ("GC"); Employ proper assay procedures and conduct analyses of chemical compositions of raw materials, manufactured products, and various samples using HPLC and GC; Assist team to conduct analytical method transfers to quality control labs; and implement Good Laboratory Practices ("GLP") procedures to ensure compliance with U.S. Food and Drug Administration ("USFDA") regulations. 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: Perform detailed review of analytical test results data to ensure technical correctness and accuracy; and interpret and evaluate results properly. 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; Perform initial and stability testing for R&D batches and demonstration batches to support formulation development. Perform Various Functions within Laboratory: Employ GLP procedures to maintain laboratory equipment; and perform laboratory instrumentation qualification, preventative maintenance, calibration, and minor repairs with proper documentation. Implement Methodologies for Analytical Development: Implement quality-by-design ("QbD") methodologies for Analytical Development for robust product development.

Requirements: Bachelor's degree in Chemistry, Pharmacy, Pharmaceutical Sciences, or a closely related field plus 2 years progressive experience as Analytical Scientist or similar role. Prior experience must include pharmaceutical analytical development or quality control; and the use of chromatographic HLPC/GC, spectroscopic, and solid-state characterization techniques. Qualified Applicants must send resumes to ... ref: AS/HY. Direct applicants only.