Manager, Analytical Development-API

Our Culture - Come Discover Us
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: August 3 - August 9, 2006.

QUALIFICATIONS:
* Ph.D. or Master of Science or BS in chemistry or pharmaceutics. Ph.D. or master are preferred
* Minimum of six years analytical experience in the pharmaceutical industry with Ph.D., minimum of eight years analytical experience in the pharmaceutical environment with MS, or a minimum of ten years analytical and supervisory experience in a pharmaceutical environment with a BS degree.
* Demonstrated knowledge of project planning, resource allocation, human resources modeling, leadership techniques, production processes, and coordination of people and resources. Knowledge of principles and procedures for personnel recruitment, selection, and training.
* Demonstrated knowledge of intermediate computer skills in MS Word, MS Excel, Empower and Cals.
* Extensive demonstrated knowledge of analytical development and validation techniques, analytical instrumentation, chemical structures, degradation pathways, chemical compatibilities, and potential toxicity along with the ability to troubleshoot analytical methods.
* Demonstrated knowledge of regulatory guidelines and guidance as they pertain to analytical techniques, policies and procedures (CDER, ICH, CFR) in order to ensure compliance.
* Demonstrated ability to evaluate, motivate, and develop co-workers; to be open and to seek creative alternatives to analytical and technical problems.
* Demonstrated ability to communicate with internal customers (i.e. formulators, quality control, regulatory affairs and manufacturing) external customers (contractors) and API manufactures to ensure a smooth progression during each phase of product development.
* Demonstrated ability to analyze data and apply sound scientific judgment to support conclusions and recommendations.
* Demonstrated ability to communicate with all levels of management and to build and maintain inter- and intra- departmental relationships.
* Demonstrated ability to work long hours

DUTIES:

* Plan and execute the work of the group to achieve goals for the annual required number of ANDA filings as determined by the Vice President of Scientific Affairs.
* Provide leadership, evaluate performance, and oversee employee development within the group to minimize risk to the business and maximize value.
* Oversee the assignment of work to assure accuracy in the data generated so that reliable testing procedures and specifications are developed
* Work with Operations personnel (i.e. New Product Launch, Stability, QC) and with suppliers to transfer analytical technology and to support the launch of new products.
* Maintain knowledge of compendia changes and other regulatory guidance's provided through ICH and FDA.
* Participate in analytical patent defense preparations and deliverables to support Paragraph IV challenges to maximize product value.
* Provide technical and analytical support to Product Development, Stability, and DRA/Medical departments.
* Provide data and technical report to DRA to support filings and comment letter responses in a timely and effective manner.
* Provide analytical and technical support to Quality Control Group.
* Assure group compliance to all government and internal regulations in order to maintain our FDA license to operate.