Specialist, Purification Technical Engineering HPV (DS4)

Job Description

The Maurice R. Hilleman Center for Vaccine Manufacturing is located in Durham, NC. This state-of-the-art facility established in 2004, manufactures our lifesaving vaccines in bulk and finished forms.  Due to the importance of this facility in our Vaccine Manufacturing network, the facility has seen rapid growth in production volumes and new employees over the last several years; currently Durham employs 1,000+ people.

Durham’s Technology Transfer Specialist will be an energetic, technical leader with strong interpersonal, communication, and collaboration skills responsible for implementation of technology transfer process knowledge, post approval support, and post commercial process enhancement activities for pipeline vaccine programs.

This position will primarily support the downstream purification process and support functions for the technology transfer of our Company's HPV vaccine drug substance. Additionally, this role will contribute to the performance and results of a department, provide technical guidance, and anticipate and interpret client and/or customer needs to identify and implement solutions. Off-shift and weekend coverage will be required based on business unit needs and specific assignments.

The role encompasses technical services support in the areas of equipment and automation systems, validation, deviation management and product franchise. Specific assignments may be focused in one area or span across multiple areas of focus.

Travel: 10% of the time

Responsibilities may include but are not limited to:

•    Provide downstream purification process engineering technical/team support for commercial technology transfer, and qualification studies associated with the development and implementation of processes, systems and facilities related to vaccine drug substance and key intermediates

•    Actively participate on cross-functional manufacturing teams to advance project goals and deliverables related to the vaccine process

•    Lead technical studies, projects and author documentation associated with site commercialization efforts

•    Provide deep SME knowledge for manufacturing investigations support (product and process deviations and complex material-related events)

•    Collaborate with internal/external partners, e.g. Other Company sites, Global Teams, Procurement, Raw Material & Component Suppliers

•    Develop effective data analytics methodologies, including statistical process control, and deepening process understanding

•    Author, review, and/or edit technical documents to support regulatory filings including technical pro