Associate Specialist, Engineering

About the role

The Maurice R. Hilleman Center for Vaccine Manufacturing is located in Durham, NC. This state-of-the-art facility established in 2004, manufactures our Company’s lifesaving vaccines in bulk and finished forms. Due to the importance of this facility in our Company’s Vaccine Manufacturing network, the facility has seen rapid growth in production volumes and new employees over the last several years, as well as future anticipated growth as part of the new product vaccine tech transfers to the facility.

Responsibilities

• Provide technical hands-on support in execution of lab-scale experiments in at least one of the following areas: buffer/media preparation, cell/tissue culture, particle isolation, or product lyophilization.
• Execute bio-analytical assays for in-process and post-process samples (can include potency assays, metabolite analysis, moisture analysis, FTIR, SEM-EDS, UV/Vis, etc).
• Perform particle isolation, microscope imaging, and particulate analysis using analytical equipment to determine origin of particulate submissions with quick turnaround to support manufacturing investigations at the site.
• Auxiliary in design and execution of lab experiments to support process characterization, commercial technology transfer, and qualification studies associated with the development and implementation of bulk processes, systems and facilities related to pipeline vaccine bulk products.
• Execute experimental studies as needed for investigational, developmental, or continuous improvement projects for our Company's existing Durham vaccine products (investigational and/or developmental studies).
• Troubleshoot equipment and assays as needed.
• Ability to support off-shift or weekend work if needed.
• Author and present experimental design proposals, technical reports and documents.
• Compile process data and employ statistical tools for experimental analysis and process monitoring.
• Actively participate on cross-functional manufacturing teams to advance project goals and deliverables related to vaccine processes.

Requirements

• Minimum Requirement: Bachelor’s Degree or higher in Engineering or Sciences, with relevant academic experience with at least one (1) year of relevant experience.
• Preferred Experience: Vaccine or biologics manufacturing within an aseptic, cGMP environment; Hands-on experience in large molecule manufacturing or bio-analytical assays; Experience designing experiments and authoring technical documentation; Solves Technical Problems Independently; Strong Attention to Detail; Ability to foster collaborative work environment; Demonstrated systematic problem-solving skills.

Skills

• Strong leadership, interpersonal and communication skills (written and oral).
• Current Employees apply HERE
• Current Contingent Workers apply HERE