Technical Program Manager

Our products and manufacturing processes are highly dependent upon consistent and dependable supply of raw materials. Therefore, the robustness of our raw material supply chains represents both risk and opportunity to our ability to supply customers with products of the highest quality.

In a dynamic global marketplace, it is more important than ever to develop a strong supply base, and in some cases to establish multiple suppliers for the same material.

Second Sourcing has thus been identified as a critical initiative to maintain our ability to supply products securely. The Technical Program Manager in the Process Solutions Value Stream is responsible for end-to-end development and execution of our Second Sourcing and risk mitigation activities.

Reporting to the Value Stream Technology Advancement office, this individual will work cross-functionally with Operations, Quality, R&D, Marketing, and Procurement to prioritize materials for second sourcing, and then to validate new material sources all the way through to final commercial product.

Second Sourcing is a strategic and highly visible activity with strong management support at all levels. The Technical Program Manager will receive exposure throughout the organization and will have the opportunity to substantially improve our manufacturing agility and resiliency.

Specific Responsibilities : Identify and prioritize material most in need of additional sources, based on the feasibility of qualifying a second source and the impact that a second source will have.

Direct and oversee all aspects of material qualification from feasibility trials through final implementation, including in some cases material characterization, sub-assembly production (e.

g. membrane), and final product production.Develop and implement multi-site project plans, including (but not limited to) the determination of terminal buy quantities, risk assessments, documentation, developing and maintaining annual project budget, overall project schedule, validation runs, conversion strategies and product stability studies post change.

As part of a multi-functional Change Team, determine customer notification requirements for specific sourcing changes and prepare customer summary reports.

Provide timely stakeholder updates and identify risks to the overall program execution or success.Oversee post implementation hyper-care phase to monitor the performance of process and product performance of new raw materials.

Who You Are : Minimum Qualifications : Minimum of Bachelor of Science / Engineering degree with emphasis in plastics, materials, or chemical engineering10+ years experience in Life Science or related industry.

Preferred Qualifications : Deep knowledge of injection molding and / or polymer science a big plusKnowledge of and experience with external Quality regulations & standards, including the current ISO 9001, GMP, FDA and EU food contact directives, & other regulations, as applicableIn-depth knowledge of Quality Systems (Exception, Investigation, CAPA, Risk & Change Management), with experience in establishing, improving, managing & assessing Quality SystemsDemonstrated success in managing complex global programs, including leading risk assessments and FMEA’s, managing teams, creating and tracking detailed project schedules and developing and managing project budgetsAbility to work in a matrix team environment with demonstrated capability to influence and manage w / o authorityEffective communication skills both at senior management and team levels