Specialist III - BI Launch - Process Technology, 1st shift

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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 who wish to apply must apply within the posting period to be considered: posting period is 8/8/06 - 8/14/06

QUALIFICATIONS:
* PhD in scientific discipline, preferably in Pharmacy, with a minimum of two (2) years experience in either Formulation/Process Development or production in the pharmaceutical industry; alternatively, MS in scientific discipline with three (3) to eight (8) years experience in Formulation/Process Development in the pharmaceutical industry
* Minimum of two (2) years experience in solid dosage pharmaceutical technology transfer, product development or manufacturing
* Demonstrated knowledge of pharmaceutical production environment with emphasis on scale-up/optimization, validation and technical knowledge of pharmaceutical processing equipment, and cGMP compliance and FDA filing requirements
* Demonstrated ability to initiate and lead projects or issue-based teams to successful outcomes; Project Management Qualification desirable
* Knowledge of statistical tools (e.g. DoE, Multivariate Analysis)desirable
* Demonstrated ability for independent work requiring attention to detail with scientific judgment and professional competency; ability to follow directions; ability to work in a team approach to accomplish tasks assigned; ability to build strategic working relationships
* Demonstrated ability to effectively communicate project outcomes/updates throughout the organization and the ability to make presentations to international project teams
* Intermediate knowledge of work processing: Powerpoint, spreadsheet (report formatting, graphing, formula and calculation generation), and familiarity with database programs

DUTIES:

* Close Cooperation with the Pharmaceutical Development Departments based on the boundaries defined by the BI Drug Product Development Guidance through active participation and open communication within international R&D Subteam meetings, Operations Subteam meetings and CMC Subteam meetings representing the Launch Site as the assigned Process Engineer. This includes review, challenge, support and follow-up of the Development Process during Milestone Meetings 1-5 while the NCE Drug Product is under development in R&D and Takeover of the Project Lead for the NCE Drug Product after Transfer (Milestone 5) and ensuring the product launch for the new Drug Product under technological aspects.
* The Launch Site can either be BIRI or an assigned 3rd Party Manufacturer.
* Establishment and lead of a local interdepartmental Project Team at BIRI as a Project Manager including team members from e.g. Manufacturing, Packaging, Engineering, Purchasing, Quality Control, Quality Assurance, Product Launch Department, Planning in order to ensure the readiness of the site for a timely Launch of the NCE Drug Product.
* Assist R&D in formulation development and scale-up by using technical knowledge and plant experience to assess new processes and provide input in regards to equipment/parameter selection to assure the implementation of robust manufacturing processes.
* Coordinate and manage Scale-up/Evaluation trials, DoE trials, Transfer-, Registration- and Validation lots to support the timely Launch of the NCE Drug Product and ensure that new products meet all requirements for quality, manufacturability and cost.
* Prepare the necessary documentation like Technical Protocols/Reports, Validation Protocols/Reports, Master Formula Cards, Registration Documents and other documents for assigned products/projects to meet established project timelines and to ensure cGMP documentation for any inspection.
* Strive for, evaluate and implement innovative production technologies or online control methods in order to improve existing or new processes and prevent deviations and rejections.
* Assist with root cause analysis, CAPA, review, and approve any necessary investigational reports to facilitate rapid closure of deviations and ensure actions are taken to prevent recurrence
* Perform peer review and/or approval of documentation to ensure right-first-time performance of department and to communicate specialized expertise across the department
* Other duties as assigned to support objective of Operations Department