Operations

• The Analytical Research & Development (AR&D) Stability Operations & Compliance department of our company Research Laboratories Division is seeking applicants for a stability operations senior specialist position available at the West Point, Pennsylvania research facility.
• The Stability Operations Senior Specialist will work as a part of the integrated Stability Operations & Compliance team and drive a culture of quality and operational excellence across the global AR&D network.
• The Stability Operations Senior Specialist will oversee and manage GMP stability studies and logistics for our large molecule portfolio in collaboration with our AR&D scientists.
• The key responsibilities of this role will include: Management of GMP stability studies, including detailed planning, coordination across networks, and implementation of stability studies for the large molecule portfolio, in accordance with all applicable regulatory requirements.
• Collaboration with internal and external partners in a cross-functional environment to drive compliance and operational excellence for stability studies.
• Evaluation of stability data, including statistical analysis and trending, investigating out of specification stability results, and communication with integrated project teams for biologics, vaccines, and/or devices.
• Maintain accurate records including sample inventory and sample chain of custody, leveraging digital systems (e.g., LIMS, Benchling, electronic notebook, electronic document management systems).
• Execute deviations and investigations, Change Management records, manage GMP documentation including stability protocols, Standard Operating Procedures (SOP), and GMP data management.
• Candidates should be able to function independently and be able to collaborate in a dynamic, integrated, multidisciplinary team environment.
• Effective communication skills, eagerness to adapt and learn, and a desire to conduct research and influence the field are essential attributes.
• As a member of our team, you will be joining scientific problem solvers who are dedicated to creating the life-changing medicines of tomorrow.

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Supervisor DC Operations – WKND Friday - Sunday, 7:00am - 7:30pm