Seeking a Scientist IV for a 2 year assignment in Spring House, PA.
Job Description: Applying multiple years of clinical testing laboratory experience, this position has a leadership role in Bioanalytical sample testing activities in support of Clinical studies. Specifically, the successful candidate will have daily participation in PK/PD and biomarker analyses, review and approval of results in LIMS, method improvements and new method dev/val., and authoring/reviewing SOP, protocols and reports. There is an expectation of on-going contribution/ownership to process improvements targeting compliance, efficiency and productivity.
Major Duties Responsibilities: - Perform approver role in LIMS for Clinical sample testing activities. Manage inventory and testing status of clinical samples using LIMS data base systems. - Supervise and maintain laboratory activities in compliance with GMP, GLP or other appropriate regulations. - Responsible for any of writing/revising/reviewer role for SOP, protocols and reports. Assist in the review and reporting of data for submission to IND s and other regulatory submissions, pre-clinical and clinical study reports. - Support BLA documentation specific to Bioanalytical, Pre-approval inspection readiness, FDA audit SME for bioanalytical. - Analyte quantification method development, validation, method transfers and comparability. Method improvements to reduce total error and to establish stability of analyte, QC, immunoreagents and buffers. Qualification of new lots: Reference standards, new kits, new conjugates. - Mentor analysts, train new employees, and evaluate/anticipate equipment needs and lab maintenance issues. - On-going contributions and ownership of Lean Processes targeting Compliance, Efficiency and Productivity. - Review employee activities and evaluate their performance for any direct reports. - Perform other work related duties as assigned.
Other Duties: - Knowledgable of GLP required, knowledgable of cGMP strongly preferred. - Strong preference for experience with LabWare LIMS. - Skilled at scientific writing: protocols, reports and SOP, proven experience in method validation and method transfers. - Experience in training analysts. - Computer proficiency is essential in MS Word, Excel.
Required Minimum Education: 10+ years. Required Knowledge, Skills Abilities: - LabWare LIMS preferred, Proficient in MS Word and Excel. - 7+ years of people management experience. Preferred Minimum Education: PhD in Biochemistry, Cell Biology, Chemistry. Preferred Related Industry Experience: biotechnology or pharmaceutical. Preferred Knowledge, Skills Abilities: Knowledgable of QControl and QAssurance roles and responsibilities in GLP and GMP environment.
For immediate consideration please call 732-246-0215 or email to firstname.lastname@example.org
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