Commercial Stability Specialist Job

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Date: May 30, 2014 Location: Berkeley Heights, New Jersey, United States Celgene is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human health. We value our passion for patients, quest for innovation, spirit of independence and love of challenge. With a presence in more than 70 countries - and growing - we look for talented people to grow our business, advance our science and contribute to our unique culture. Position Summary The Commercial Stability Specialist is responsible for administering and ensuring GMP compliance of the Stability program for Celgene’s commercial products. The Stability program generates data to establish and support shelf-life for commercial products. The Stability Coordinator will also provide assistance as a Subject Matter Expert to the Analytical R&D and Global Regulatory CMC departments in support of the stability program. Responsibilities will include, but are not limited to, the following: • Serve as a subject matter expert (SME) for stability questions related to commercial products within ICH/FDA guidelines and approved submissions / commitments. • Accountable for the design/development, implementation, ensuring compliance readiness and governance of stability protocols for commercial products. • Responsible for the tracking and trending of stability data which includes performing scientifically sound data analysis, including statistical analysis, for comparability studies, shelf life, degradation rates, trending and trend limits, and specification changes. • Author/provide scientific and technical representation of stability in all stability relevant sections for Regulatory Submissions, Regulatory Agency responses, and APR/APQR. • Manage and monitor milestones and detail timelines for commercial products while providing timely and transparent communication. Appropriately execute, stage, manage and close all stability studies for commercial products. • Partner with QC and R&D laboratories as well as Quality Assurance, Technical Operations, Global Regulatory CMC functions and Contract Service Providers. • Works with CSP Sr. Specialist / CSPs for contracts to perform stability testing. • Reviews stability data, as appropriate. • Other duties and special projects as assigned by management. Skills/Knowledge Required: • BS/BA degree with a minimum 3 years or MS/MA degree with a minimum 1 years in analytical chemistry or relevant equivalent experience. • Knowledge of cGMP in the pharmaceutical industry • Experience with use of a LIMS system in Stability is a plus • Excellent problem-solving, verbal and written communication skills • Must have strong interpersonal and communication skills, be a team player • Must be an individual with proven initiative and demonstrated accountability Preferred Skills/Knowledge: • Technical writing skills • Developing knowledge of Regulatory guidances (EU/ICH/US) • Basic scientific and technical knowledge Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S. Qualifications BS/BA with minimum 3 years or MS/MA with minimum 1 year in analytical chemistry or relevant equivalent experience. Req ID: 14001180 Primary Location: United States-New Jersey-Berkeley Heights Job: Manufacturing Organization: Celgene Corporation Schedule: Regular Shift: Standard Employee Status: Individual Contributor Job Type: Full-time Job Level: Day Job Travel: No Job Posting: 2014-05-01 00:00:00.0
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