Senior Associate Director - Manufacturing Operations, Cell Culture
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POST DATE 9/16/2016
END DATE 10/29/2016
Boehringer Ingelheim Fremont, Inc
JOB DESCRIPTIONAPPLY Boehringer Ingelheim Fremont Inc. - Boehringer Ingelheim is one of the world's leading biopharmaceutical contract development and manufacturing organizations. Boehringer Ingelheim Fremont Inc. is currently searching for a talented and innovative Senior Associate Director leads the clinical and commercial Cell Culture Operation in the Drug Substance Manufacturing group at our Fremont, CA location.
The Senior Associate Director provides leadership, direction and oversight to the associated teams. Responsible to meet financial and quality performance goals. In addition, this position is accountable to provide scientific, technological support during feasibility, technical planning phase, process transfer, launch, and initial supply as well as supporting regulatory inspections and audits from global authorities.
As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in a number of ways to foster a healthy working environment, meaningful work, diversity and inclusion, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees.
Duties & Responsibilities:
* Serves as leader in the manufacturing area assigned.
* Accountable for effectively leading, driving the rapidly growing organization
* Plans, directs, and effectively manages work to meet quality, productivity and efficiency goals:
- Ensures the safety of work practices in accordance with the BIFI safety program
- Ensures that all production activities are in compliance with CGMPs
- Ensures staff is sufficiently trained to perform their job responsibilities
Provides technical subject matter expertise for the area
- Undertakes mid and long-term strategic planning and supervision of projects that require cross functional interaction
- Oversees, either directly or indirectly, investigations and process deviations
* Responsible for the department annual budget and quarterly forecasting processes. Manages head count and expenses to meet approved spending plan while achieving all departmental commitments and project objectives.
* Accountable for New Process/Product Implementation including process transfers, launch and manufacturing of mammalian derived drug substance. This includes providing scientific and technological support, supporting the technical project phase, process transfer, scale-up, validation, troubleshooting activities and regulatory filing activities.
* Provides effective leadership according to the BI leadership principles. Motivates, retains and develops key employees. Builds and sustains employee engagement by creating an environment where individuals and teams can excel.
* Actively engaged in the identification, sharing and adaptation of best practices cross-functionally and between manufacturing sites. Implements/supports business process for continuous improvements.
* Identify and establish state-of-the-art technologies for large scale drug substance and drug product manufacturing including asset management and investments.