Job Description

Summary of Purpose/Major Responsibilities:

This position takes a leadership role in identifying and resolving issues of safety, compliance, and efficiency that impact the supply of bulk Biologic vaccine products.  This position contributes as a member of cross-functional teams to support influenza antigen manufacturing in B79.  Each team may have representatives from M-Tech, GEM, Quality Assurance, Sterility Assurance, and Planning, requiring a high degree of relationship building, communication, technical knowledge and leadership.

Key Accountabilities:

Responsibilities include small/medium project scope and solution development, the use of statistical/lean/FMEA and other methods to performing preliminary options analysis, change control development and execution, commissioning and qualification documentation development and execution, project execution tracking and project completion activities.

Represent factory with internal and external suppliers and customers:  Support technical operational leaders with equipment vendors and material suppliers to ensure effective performance of Swiftwater operations.  With supervision, represent factory leadership and provide input and guidance to external projects.

Become a Subject Matter Expert (SME) on the state of the industry trends for Bulk Manufacturing. Through continuing education, remain current with industry knowledge, trends, and best practices. As a SME, provide strategic input required to stay competitive in the bulk vaccine manufacturing market.

Attend all L1 +QDCI board meetings to gather and report out on issues/opportunities existing on the shop floor.

Actively develop, promote, and implement safe work practices to ensure safe working conditions for all employees.

Context of the Job/Major Challenges:

Will identify, investigate, gain consensus and resolve issues that impact the supply of Antigen products.  They will support projects and lead small projects to maximize the safety, quality, efficiency and effectiveness of the antigen factory.

Is tasked with leading change.  This position is a responsible interface between operations and support functions, and is expected to work effectively with partner functions such as Quality and Manufacturing Technology to ensure continuous improvement of the assigned factory.

Will provide operational input to the bulk antigen continuous improvement team by direct participation and integration into factory operations.  This is accomplished through a high degree of shop floor presence and participation with other functions in the focus factory as directed by the CI team leader.

Will serve as a scientific and technical interface with suppliers and customers of equipment and materials.

Will lead change controls, small process improvement initiatives, and other activities as assigned.  The Manager, Continuous Improvement will assist with deviation investigations and trouble-shooting of production equipment.

The ideal candidate will possess a demonstrated history of successful small project leadership including project planning, resource management, execution and closure; experience in the areas of customer support, operational excellence, and troubleshooting.  In addition, the candidate will possess process or automation knowledge of pharmaceutical equipment and processes, and technical knowledge in cGMP manufacturing.

Requirements:

Minimum B.S., Biochemical, Mechanical or Chemical Engineering, or similar technical field.

Minimum 2 years experience in a cGMP role.

Knowledge of GMP requirements and commissioning and qualification would be beneficial.