Scientist III, Analytical Development - Active Pharmaceutical Ingredient

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Boehringer Ingelheim is a family-owned company that is in the business of providing our customers with pharmaceutical and animal health products that significantly enhance their health and improve their quality of life. Our most important resource is our committed, creative and determined employees whose energy is focused on discovery, development and delivery of our innovative products to those who need them. The employees of Boehringer Ingelheim are our most important competitive advantage. Our global presence and thinking provides the opportunity for employees to work internationally and on teams, offering them visibility and the ability to influence the direction and outcome of critical projects. Competitive benefit and compensation programs reflect the Company's high regard for its employees and enhance each person's ability to balance the demands of work and personal responsibilities. Every employee at Boehringer Ingelheim contributes to the company's uncompromising commitment to quality in our products, excellence in our scientific pursuits and high ethical standards of behavior. The diversity of our employees makes it possible for us to craft unique solutions to today's complex business challenges. We are an equal opportunity employer. M/F/D/V.

Job Description
Internal candidates must apply within the posting period: July 28 - August 3, 2006.

QUALIFICATIONS:
* Ph.D. in Chemistry, Pharmaceutics, or Engineering with up to three years experience in analytical chemistry in the Pharmaceutical Industry, or MS in Chemistry, Pharmaceutics, or Engineering with four to eight years experience in analytical chemistry in the Pharmaceutical Industry in the API area, or BS in a scientific discipline (chemistry preferred) with five to ten years' experience in analytical chemistry in the Pharmaceutical Industry in the API area.
* The work related experiences required include development, transfer, validation and application of analytical methods for testing and evaluating Active Pharmaceutical Ingredients (APIs). Analytical experience through the project, from initiation to ANDA filing is preferred.
* The candidate must be able to manage multiple projects at one time.
* Experience with the following analytical techniques is required: HPLC, GC, Particle Size, DSC/TGA, x-ray, MS and wet chemistry techniques. Knowledge of the critical functions/variables for each type of equipment is also required.
* Knowledge of the most current FDA/ICH guidances, and national/international Pharmacopoeias is required.
* Familiarity with DMFs and API technical packages is required.
* The candidate must be a demonstrated technical problem solver with a proven track record.
* The candidate must have demonstrated leadership capabilities and must be able to work intra- and interdepartmentally. The candidate must possess excellent inter-personal skills.

DUTIES:

* Analytical Methods- Develop/transfer, validate analytical methods for the support of API for ANDA submission. Analytical testing of APIs for raw material releases.
* Project Management - Manage the analytical aspects of the assigned projects, operating within the project timeline and communicating results to the work teams.
* Regulatory - Implement appropriate guidelines and procedures to assure compliance with cGMPs, DEA, and FDA requirements. Actively participating in preparation of FDA responses, managing the API analytical tasks.
* Problem Solving: - Identify technical problems and implement solutions.
* Prepare Technical reports and other documents required by cGMP's and department policies
* Work independently and interact on a regular and timely basis with Quality Control, Product Development, DRA and other departments as appropriate.
* Operate within the department budget.
* All other duties as assigned.