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| Associate Research Scientist IL Open (J#45480) Title: Associate Research Scientist Company: Fenwal Inc. Description Fenwal is a global medical technology company focused on improving blood collection, filtration, separation, storage and transfusion to ensure the availability, safety, and effectiveness of blood and blood components. Fenwal employs approximately 4,000 people worldwide, and operates five manufacturing centers. The company generates more than $600 million in sales, with nearly half coming from outside the United States. This position is located in our corporate office in Lake Zurich, IL. We currently have an opportunity for an Associate Research Scientist to join our Chemistry and Solutions Team. Responsibilities include: 1) Provide overall day-to-day management of all Fenwal Product stability study activities including technical and contractual relationships with outsourced service providers - Ongoing QC stability study program, - Product modification stability studies. - New product development stability studies. - Establish, confirm, monitor product expiration periods. - With QA, oversee stability out-of-specification investigation and reporting. 2) Act as primary functional interface for delivery of information and data to Fenwal regulatory affairs and internal customers. - Stability data reporting (FDA, CE Market technical files, and global registrations). - Presentation of CMC/CTD chemistry sections related to submissions and inquiries from regulators. 3) Change management for both small and medium projects relevant to this function. 4) Oversight of Fenwal compendial monitoring process - European Pharmacopeia. - US Pharmacopeia - Other Pharmacopeia - ISO 10993 - ISO 3826 Requirements - Advanced degree in Chemistry preferred; Bachelor s degree in Chemistry with relevant experience will be considered. - 5 years of related industry experience in a technology driven company environment - Prior experience within an FDA regulated laboratory environment of drug and medical device industries including GMP/GLP/GDP operations - Experience in a drug product stability testing function - Working knowledge and experience with modern instrumental and classical analytical chemistry testing procedures - Detail oriented with demonstrated ability to prepare and review complex reports with large amounts of data - Strong written and verbal communication skills - Strong project management skills - Strong interpersonal skills and the ability to work with across functions Fenwal, Inc. offers an excellent salary and benefits package including immediate medical, dental and vision coverage, as well as life insurance, disability, 401K with company match and profit sharing. Fenwal is an Equal Opportunity Employer. We encourage and support a diverse workforce. | |||
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