Sr. Manager, Bioanalytical, Compliance and Stability Services

Shift: A ShiftLast Updated: 7/21/2006Duties and Responsibilities: This position is responsible for managing the provision of analytical support provided to ongoing product development projects, development of analytical methods, provision of analytical support to the development of products compilation of the analytical portion(s) of the chemistry manufacturing control (cmc) section of submissions. Manage and train analytical chemist under their supervision. Develop analytical methods to support the development of new products within the budgetary guidelines. Provide in-depth analytical support to product development activities. Develop and validate analytical methods to support product development. Design and implement stability protocols and special studies in support of product development activities. Provide in-depth analytical support to product development activities exhibiting an understanding of the state of the art resources/equipment available in the next market. Demonstrate an understanding of analytical chemistry at the research level Represent the department at project meetings. Contribute to the leadership of projects through the setting of realistic timelines and coordination of departmental activities so as to meet those timelines.
REQUIREMENTS
Minimum qualifications: Ph.D. degree in Analytical Chemistry with a minimum of 2 years relevant experience or MS degree in Analytical Chemistry with a minimum of 5 years relevant experience or BS degree in Chemistry with a minimum of 12 years relevant experience. An in-depth understanding of and experience in GMPs and regulatory guidance. Experience with the development and validation of analytical methods. Knowledge or experience in preparation of documents for CMC sections of INDs, ANDA and/or NDAs. Must have a strong record of accomplishments in analytical chemistry and/or analytical development with excellent quantitative and qualitative analytical skills. Ability to think strategically and creatively along with exceptional communication and interpersonal skills. Have proven people management skills. An expertise in evaluating third party data preferred. An understanding of the basic statistical concepts and working knowledge of one or more statistical and other technical software packages. Strong computer skills e.g., Excel, Word, etc. Excellent presentation skills. DEY supports diversity in the work place. We are an Equal Opportunity Employer. HOME | CAREERS | BUSINESS DEVELOPMENT | PRODUCTS | CORPORATE PROFILE
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