The Pharmaceutical Analysis & Digital Technologies (PADT) External Capabilities, Validation, and Compliance (ECVC) department of our Research Laboratories Division is seeking applicants for a for a Senior Specialist position available at the Rahway, New Jersey research facility. The Stability and Sample Management Senior Specialist will work as a part of the integrated Stability Operations team and drive a culture of quality and operational excellence across the global analytical network. The Stability and Sample Management Senior Specialist will oversee and support GMP stability and sample management logistics in collaboration with our analytical scientists. The key responsibilities of this role will include:Collaboration with internal and external partners in a cross-functional environment to drive compliance and operational excellence. Receive analytical samples from partner groups according to established procedures. Aliquot, prepare, and label analytical samples for distribution to on-site testing laboratories or shipment, including the coordination of international shipments. Manage and maintain a suite of GMP stability chambers in a state of permanent inspection readiness. Provide technical supervision to a small group of specialists. Manage analytical samples for pipeline stability studies. Maintain accurate records including sample inventory and sample chain of custody, leveraging digital systems (e.g., LIMS, Benchling, electronic notebook, e. Logs). Stability study builds in LIMS and data management. Perform deviations and investigations, create Change Management records (where necessary), manage GMP documentation including Standard Operating Procedures (SOP). Support logistical requirements for capital expansions including facility/ CTU requirementsand capacity planning. Continuous improvement to maintain state-of-the-art stability infrastructure to meet Globalcompliance standards. 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. Education Requirements: M. S. with 3 years of post-degree relevant industry experience or B. S. with 7 years of experience. Required Experience and Skills. An effective collaborator with the ability to work both independently and in a cross-functional team setting to deliver on complex objectives. Proven track record of strong technical and innovative problem solving. Desire and ability to learn new concepts outside of core expertise and training. Excellent communication skills, demonstrated creativity, and effective interpersonal skills. Experience working within a GMP environment. Understanding of GMP policies and procedures. Related industry experience supporting management of analytical samples. Preferred Experience and Skills While not required, experience in one or more of the following areas is beneficial. Demonstrated commitment to diversity and inclusion. Experience leading a team for a common goal. Experience in Auditing and Compliance within pharmaceutical industry, including change management and deviation management. Experience supporting internal and external quality audits. Experience supporting logistical requirements for capital expansions including facility/ CTU requirementsand capacity planning.#eligibleforerp. Required Skills: Adaptability, Analytical Chemistry, Change Management, Continuous Process Improvement, Data Analysis, Diversity and Inclusion (D&I), Experimentation, GMP Compliance, International Regulatory Compliance, Investigation Procedures, Lab Equipment Maintenance, Laboratory Management, Operational Excellence, Personal Initiative, Pharmaceutical Microbiology, Quality Auditing, Regulatory Compliance, Reviewing Literature, Scientific Research, Statistical Analysis, Strategic Planning, Teamwork, Technical Writing. Preferred Skills: Current Employees apply HERE - Current Contingent Workers apply HEREUS and Puerto Rico Residents Only:Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here