Senior 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 Senior 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 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 and leadership 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 e.g. buffers, media and cleaning solutions

• Mentor junior specialist

• 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)

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

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

• Author, review, and/or edit technical documents to support regulatory filings including technical reports and risk assessments

• Author or approve Change Control documentation for complex process, validation, analytical, equipment, facility/utility and/or automation changes. Managing on-time implementation and close-out to meet project, production and supply timelines.

• Lead aspects of regulatory inspections by presenting and defending technical documentation, investigations, and change controls

• Lead implementation and evaluation of innovative process technologies, continuous process improvements and post launch process enhancements

• Provide subject matter expertise support to ongoing manufacturing activities.

• Participate in the equipment specification, selection/procurement, and qualification phases of vaccine capital projects

Position Qualifications:

Education Minimum Requirement:

• Bachelor of Science Degree in Chemical Engineering, Biochemical Engineering, Bioengineering, or related life science field with a minimum of five (5) years of relevant experience; a Master of Science Degree with a minimum of three (3) years of relevant experience; or a Ph.D. with relevant academic experience.

Required Experience and Skills:

• Experience in vaccine or biologics manufacturing within a cGMP environment

• Experience authoring technical documentation (technical investigations, protocols, reports, or change controls)  within a cGMP context

• Proven leader with influence and outstanding communication (written & presentation) skills

• Demonstrated systematic problem-solving s