Laboratory and Manufacturing Coordinator - IDS - Hospital of the University of Pennsylvania
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Job ID: 135851
Category: Pharmacy
Work Type: FT
Location: Philadelphia, PA, United States
Work Schedule: Days
Description
Penn Medicine is dedicated to our tripartite mission of providing the highest level of care to patients, conducting innovative research, and educating future leaders in the field of medicine. Working for this leading academic medical center means collaboration with top clinical, technical and business professionals across all disciplines.Today at Penn Medicine, someone will make a breakthrough. Someone will heal a heart, deliver hopeful news, and give comfort and reassurance. Our employees shape our future each day. Are you living your life's work?
Summary:
- The IDS Laboratory and Manufacturing Coordinator, provides hands-on training to new hires, supervises daily production and testing activities to assure adherence to procedures and SOPs applicable to laboratory and manufacturing activities, conducts laboratory investigations when needed, participates in cross-functional teams to understand priorities. The coordinator will have strong relationships with researchers in problem solving to achieve their clinical trial goals. Communication with the Assistant Director for Clinical Operations and the Quality and Regulatory Clinical Pharmacy Specialist to ensure research needs are met and compliance with regulatory standards is met will be paramount in this role. Oversight of method development, manufacturing practices and testing procedures is expected of the Coordinator.
Responsibilities:
- Schedules testing/review of investigational products, in-process, finished product, and stability samples, complaint samples, samples from process and cleaning validation activities
- Drives effective and efficient processes enforcing compliance to data integrity, SOPs, specifications, methods, and USP through real time verifications of appropriate platforms. Support analysts by trouble shooting methods, instrumentation and execution of the tests
- Initiates change controls for revisions to any controlled document (SOPs, methods, stability protocol and specification)
- Reviews changes in compendial methods for applicable products and notifies management of such changes in order to determine appropriate course of action
- Participates in analysis when required for special projects. When required, summarizes data for in-process testing, testing and release of finished products, and stability data for trending
- Attends production planning meeting and updates list with delivery dates committed, track delivery dates with respect to committed dates. Submits a list containing weekly samples-in and out
- Reviews method transfer protocols/reports/vendor qualifications reports/USP monograph evaluation reports/training records. Identifies training needs and provides necessary training to the analysts as and when needed
- Serves as subject matter expert for Laboratory Information Management System (LIMS) implementation, maintenance and enhancement
Credentials:
Education or Equivalent Experience:
- Master of Arts or Science (Required) in Chemistry, Pharmaceutical Sciences with prior experience with research
- Ph.D. preferred in Chemistry, Pharmaceutical Sciences
Live Your Life's Work
We are an Equal Opportunity and Affirmative Action employer. Candidates are considered for employment without regard to race, ethnicity, color, sex, sexual orientation, gender identity, religion, national origin, ancestry, age, disability, marital status, familial status, genetic information, domestic or sexual violence victim status, citizenship status, military status, status as a protected veteran or any other status protected by applicable law.
