Director - Manufacturing - Affymetrix - Cleveland

Job description
Position Description
The Director of Manufacturing is responsible for the GMP manufacturing activities at the Affymetrix Cleveland facility. This responsibility includes all aspects of biochemical and molecular biology production and quality control functions. The manufacturing operation is comprised of a workforce of about 40 individuals ranging from entry level production staff to scientists involved in product and process scale-up and optimization. Currently, the position requires management of a single shift, five day operation. This leadership role requires effective cross-functional working relationships with Quality Assurance, Planning, and Engineering groups which support day-to-day operations; interacting with Product Development and providing support for Regulatory submissions related to commercial and clinical products manufactured at this facility. Success is measured by one-time, defect free, production of high quality reagent products with efficient and effective use of resources, minimization of deviations, strong personnel management, and effective collaborations with supporting departments. The ideal candidate will have a solid track record of leading high mix and high complexity production operations under ISO and FDA regulations.

Core Responsibilities
- Responsible for implementing the strategic direction, objectives and goals of the manufacturing and QC functions in areas such as leadership and development of people, organizational excellence, Lean principles, Good Manufacturing Practices, and new technologies to assure the long-term health of the site.

- Accountable for all manufacturing activities, ensuring product availibility, maintaining a high level of cGMP and quality compliance and delivering direct and indirect cost reduction targets, and, continuous product realization cycle time improvements.
- Consistently meet production schedule on a weekly, monthly and quarterly basis and ensure alignment of manufacturing schedules to meet to corporate goals and objectives. This includes continuous communication with Planning, Quality, and Engineering teams to effective coordination and execution.

- Ensure that equipment and processes are appropriately maintained, validated, and approved for specified manufacturing activities.
- Ensure appropriate training of all manufacturing personnel on equipment, processes and facility procedures as well as safety is maintained and up to date.

- Utilize proper metrics for measuring performance in the areas of quality, safety, cost management, capacity management, and operational efficiency.
- Manufacture to a high, and continuously improving, level of GMP compliance.
- Regularly communicate production status and output to senior plant management and to corporate management

Qualifications
Required
- Track records of demonstrated ability to motivate and develop resources from supervisor to director levels.
- Demonstrated work history in leadership of people and projects of a diverse nature.
- Ability to lead manufacturing operations and develop leaders throughout the organization.
- Excellent communication skills with ability to communicate upwards and downwards. Ability to lead and communicate orally, in written documents, and in formal presentations is required.
- 15+ or more years of GMP experience
- Previous experience in regulated environment

Education and Experience
Bachelor's degree required; preference given to candidates with advanced degrees and degrees in Engineering, Science or Business; 15+ or more years of GMP experience required; previous experience in regulated environment; consideration will be given to other relevant experience and education.

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