Associate Specialist, Engineering

Job Description

Durham’s Technology Transfer Associate Specialist will be an energetic, technical team member 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 for the technology transfer of our Company's HPV vaccine drug substance. Additionally, this role will support future upstream fermentation and aluminum adjuvant manufacturing processes. The individual will contribute to the performance and results of a department, provide technical guidance, and on floor support of automation and processing excursions. This role will include night shift and weekend coverage as required to support continuous manufacturing.

The role encompasses technical services support in the areas of equipment and automation systems, validation, deviation management and product franchise.

Responsibilities may include but are not limited to;

• Provide technical/team support on the production floor 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

• Respond to process automation holds and alarms working cross-functionally with operations and quality.

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

• Support technical studies and author documentation associated with site commercialization efforts

• Provide 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 protocols, reports and risk assessments

• Manage on-time implementation and close-out to meet project, production and supply timelines.

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

• Evaluate and develop innovative process technologies, continuous process improvements and post launch process enhancements

• Provide post approval support and subject matter expertise support to ongoing manufacturing activities.

Education Minimum Requirement:

• Bachelor of Science Degree in Chemical Engineering, Biochemical Engineering, Bioengineering, or related life science field.

Required Experience and Skills:

• Demonstrated written and verbal communications skills

• Demonstrated systematic problem-solving skills

• Ability to foster a collaborative work environment

• 12 hour rotating shifts, 2-2-3 days/nights including weekends and holidays

Preferred Experience and Skills: