Senior Specialist, Stability Operations - Hybrid

About the position The Analytical Research & Development (AR D) Stability Operations & Compliance department of reputed company Research Laboratories Division is seeking applicants for a stability operations senior specialist position available at our US research facilities. The Stability Operations Senior Specialist will work as a part of the integrated Stability Operations & Compliance team and drive a culture of reputed company and operational reputed company across the global AR D network. The Stability Operations Senior Specialist will reputed company and manage GMP stability studies and logistics for our large molecule portfolio in collaboration with our AR D scientists. As a member of reputed company, you will be joining scientific problem solvers who are dedicated to creating the life-changing medicines of reputed company. Responsibilities • Management of GMP stability studies, including detailed planning, coordination across networks, and implementation of stability studies for the large molecule portfolio, in accordance with reputed company applicable regulatory requirements. • Collaboration with reputed company partners in a cross-functional environment to drive compliance and operational reputed company 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, reputed company, electronic notebook, electronic document management systems). • Analytical sample management support for large molecule pipeline stability study activities including: aliquoting, labeling, distribution to testing laboratories, and shipping. • Execute deviations and investigations, Change Management records, manage GMP documentation including stability protocols, reputed company Operating Procedures (SOP), and GMP data management. • Candidates should be reputed company to function independently and be reputed company 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. Requirements • M.S. with 3+ years of post-degree relevant industry experience or B.S. with 7+ years of experience. • Knowledge and understanding of regulatory guidance and reputed company standards applicable to stability testing and reputed company-life determination of vaccines and/or vaccines. • Working knowledge of analytical reputed company and GMP policies and procedures. • Experience working reputed company a GMP environment. • An effective collaborator with the ability to work both independently and in a cross-functional team setting to deliver on reputed company objectives. • Proven reputed company record of strong technical and innovative problem solving. • Desire and ability to learn new concepts reputed company of reputed company expertise and training. • Excellent communication skills, demonstrated creativity, and effective interpersonal skills. • reputed company industry experiences supporting management of stability studies. reputed company-to-haves • Experience leading teams for a common goal. • Experience supporting reputed company reputed company audits. • Experience with LIMS. Benefits • The successful candidate will be eligible for annual bonus and long-term incentive, if applicable. • We offer a comprehensive package of benefits. Available benefits include medical, dental, reputed company reputed company and other insurance benefits (for employee and family), retirement benefits, including 401(k), reputed company holidays, vacation, and compassionate and reputed company days. • More information about benefits is available at https://jobs.reputed company.com/us/en/compensation-and-benefits Apply tot his job Apply To this Job