Your Role:
The Head of IPS Operations – Biologics will report into the Head of Operations for Ewing and Spruce in the Biologics Operations Cluster. The role is responsible for providing strategic and operational leadership to assigned site in order to achieve the financial, productivity, and growth objectives consistent with corporate and divisional goals.
- Direct the Up-Stream and Down-Stream operations in a manner consistent with quality standards to ensure an adequate supply of products are produced at the lowest cost, on schedule, and in the most efficient and safest manner.
- Responsible for implementation and maintenance of manufacturing systems required to produce current and future products using existing or new technologies. Translation of the operational manufacturing plan into financial performance ensuring operational leverage is maintained and balance with inventory strategy
- Assist in the development and adjustment of production forecasts as required to meet customer demand and service level requirements.
- Ability to work closely with internal functions such as Technology Transfer, R&D, Quality Assurance, Regulatory, Finance, Sales & Marketing, Maintenance, Human Resources and other Production sites to ensure site and cluster deliverables.
- Implement technology transfer and new product introduction as required by the Corporation’s innovation plan.
- Implement and direct the necessary systems to assure compliance with GMP, FDA, OHSA, USDA, EPA, the ISO Quality System and other regulations to assure production meets established quality and regulatory specifications.
- Direct, oversee and fulfill all HSSE related requirements for the facility, including providing necessary resources, establishing and achieving local/corporate goals, and maintaining all certifications
- As assigned, participate on Corporate, SBU, and Divisional committees. Develop strong working relationships with corporate partners who have responsibility for the sales and/or licensing of the Company’s products and technologies.
- Responsible for meeting site related performance targets: Safety and Quality Excellence, Customer Focus Supply Excellence, People Development, Margin and Asset Optimization and Technology Advancement
- Responsible for providing monthly summary of performance and reporting to Biologics Operations and Supply Chain Leadership
- Support communication around plant related supply disruptions from the Biologics cluster thru the Supply Network Team
Who you are:
- Degree in chemistry, biological science, or engineering; Advanced degree strongly preferred.
- Minimum of 3 years progressively responsible related experience in manufacturing technologies; Life Sciences strongly preferred.
- Demonstrated ability to lead a manufacturing organization of similar size and scope to meet safety, health and environmental standards.
- Demonstrated thorough knowledge of cGMP regulations for manufacturing IVD products.
- Demonstrated knowledge and familiarity with OSHA, FDA and EPA regulations; must have solid knowledge of the ISO Quality System.
- Excellent verbal, written, and interpersonal communication skills, including the ability to motivate and influence others to act. Excellent presentation skills, including the ability to present material in a clear, concise manner, appropriate to the level of the audience.
- Demonstrated knowledge of personal computer software in a business environment. Microsoft Office preferred. Demonstrated aptitude to learn and operate the Company’s computer systems related to the position (SAP, Oracle, Accolade, etc.). Demonstrated knowledge and experience working with computerized MRP or ERP systems.
- Ability to travel domestically to accomplish the duties of the position; overnight stays required; possible international travel. Travel is expected to be approximately 10%.
- Experience in Product life cycle management and communicating strategies with business partners
- Experience incorporating automated solutions in drive operational strategies around cost reduction, reduction in lead time, and control of process variability