Sr. Research Scientist, Analytical Development

This key role provides leadership and support of product development activities within the Analytical and Quality Control department by mentoring staff, participating on project teams and interacting within and across functional areas, providing technical expertise in method development, validation and transfer, supporting CMC in e-CTD regulatory submissions. Essential Functions: • Developing, validating and transferring analytical methods to support product development • Performing drug product lot release and stability testing, raw material testing, in-process testing, test cleaning assays and executing of method validation studies • Analyzing and reviewing test results • Writing Incident and Deviation Reports (IR/DR) • Investigating Out-of-Specification/Out of Tolerance (OOS/OOT) • Troubleshooting laboratory equipment • Training of Analytical Development (AD)and Quality Control (QC) laboratory personnel • Writing and updating AD and QC Standard Operation Procedures (SOPs) • Interacting with Quality Control, Quality Assurance, Manufacturing/Operations, Research and Development, and other cross-functional groups within the organization Requirements: • BS or MS or Ph.D. degree in Chemistry, Life Sciences, Physical Science or a related scientific discipline. • A minimum of 12 years experience with a BS degree or 8 years experience with a MS degree or 5 years experience with a Ph. D. degree working in a Pharmaceutical, Biopharmaceutical, or Biotechnology industrial environment. • Demonstrated cGMP analytical laboratory experience. • Familiar with Quality Laboratory Systems and processes. • Strong knowledge of chemistry with proven analytical and problem solving skills. • Experience with analytical instrumentation, associated software and equipment such as HPLC, TLC, Karl Fischer titration, USP dissolution/release rate testing, etc. ChemStation/ChemStore chromatography data system (CDS) or equivalent experience a plus. • Candidate must be a team player with excellent written and verbal communication skills.   Contact Name: Heather Keller Contact Email: Apply by Email Company:  Lab Support, a division of On Assignment Job Status:  Full Time, Employee Category:  Biotech/R&D/Science Apply Now! Email this Job to a Friend Click here to see all company opportunities