Senior Scientist - Global Product Stability Job
Location: Somerville New Jersey
Description: Johnson & Johnson is at present recruited Senior Scientist - Global Product Stability Job right now, this vacancy will be placed in New Jersey. More details about this vacancy opportunity kindly see the descriptions. Johnson & Johnson companies are equal opportunity employers.
Senior Scientist - Global Product Stability-2805130304
Description
The Global Surgery Group is comprised of the following businesses within Johnson & Johnson: Ethicon Surgical Care, Ethicon Energy, Ethicon Biosurgery, Acclarent, Biosense Webster, Cordis, Mentor and Sterilmed. With annual sales of $11 billion, the Global Surgery Group is the world's largest, most innovative surgical company. The strength of the Global Surgery Group is illustrated by the fact that more than 80% of our sales come from businesses with #1 or #2 global market share positions. We serve customers around the world, with about 60% of our sales generated outside the U.S., including a fast-growing presence in emerging markets. The Global Surgery Group is committed to innovation, with about 30% of our sales coming from products introduced in the past five years.
The Sen! ior Scientist will develop and review stability strategies/pro! tocols in support of the product development process. He/She will also be responsible for providing guidance on stability criteria that provide a fundamental understanding of the link between our product chemistry, product packaging, product performance and product shelf-life determination. He/she will also provide assistance as a Subject Matter Expert to our Regulatory and Compliance departments in support of the stability program.
Main responsibilities will include: Serve as a stability representative on multidisciplinary project teams to council on stability best practices toward successful development and manufacture of medical devices. Implement and maintain Stability Study Data Management System. Ensure documentation in support of expiry dating is in alignment with company, industry and regulatory guidelines. Provide support to Operations to identify and correct any product or process-related issues. Provide support to Regulatory Affairs through issuan! ce of interim and final reports, with corresponding data summary tables, for annual reports submitted to FDA. Train and educate associates so as to best understand stability studies procedures and policies. Ensure data files are securely stored so as to be easily retrievable. Ensure environmental chambers are maintained in accordance with FDA requirements. Ensure that stability driven insights are fully leveraged in the selection and optimization of product design during all stages of the product development process. Provide stability support/consultation to manufacturing and marketing groups mainly through outsourcing opportunities. Interact with the business unit associates to understand their product development difficulties and develop measurement methods to overcome these issues. Interact with internal J&J stability groups and external collaborators to increase the stability capabilities of the Ethicon group. Author stability program procedures, work instructions, and ! templates; provide instructor-led training for approved stability docum! ents.
Qualifications
B.S. and/or M.S. degree in a science discipline required. A minimum of two years medical device and/or pharmaceutical experience required. Comprehensive knowledge of stability operations and industry best practices required. Knowledgeable in FDA and E.U. medical device regulations, standards, and guidance's required. Experience working in QC/QA laboratory and/or manufacturing cGXP environment required. Experience leading a team project is preferred. Experience working in a team-oriented environment that embraces change, risk, and flexibility is required. Proven problem solving skills using analytical coupled with stability technologies is required. Strong interpersonal relationship and people skills required. Knowledge of Design/Process Excellence is preferred. This position is located in Somerville, NJ.
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Primary Location: North America-United States-New Jersey-Somerville
Organization: Ethicon Inc. (6045)
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This vacancy starts available on: Tue, 12 Mar 2013 12:39:39 GMT