Senior Specialist, Process Lab

At our company, we aspire to be the premier research-intensive biopharmaceutical company. The Maurice R. Hilleman Center for Vaccine Manufacturing, located in Durham, NC, is a state‑of‑the‑art facility that produces lifesaving vaccines in bulk and finished form. The Process Support Lab (PSL) at this site is seeking a Senior Specialist to lead a team of scientists and engineers and to support analytical projects within vaccine process development, technical transfer, and post‑commercial process enhancements.

• Manage PSL study leads on the analytics team.
• Serve as a subject‑matter expert (SME) in technical data analysis and mentor peers in statistical tools and graphing techniques.
• Provide technical review and/or approval of experimental design proposals, analysis, protocols, and reports.
• Leverage upstream, downstream, drug product, and analytical expertise to lead and support late‑stage process development, scale‑down model development, process characterization, commercial technology transfer, and qualification studies.
• Support work streams associated with the development and implementation of processes, systems, and facilities related to vaccine drug substance and drug product.
• Execute bio‑analytical assays for in‑process and post‑process samples and support assay qualification or troubleshooting during tech transfer and manufacturing.
• Execute experimental studies as needed for investigational, developmental, or continuous improvement projects for existing Durham vaccine products.
• Assist in the design and execution of lab experiments to support process characterization, commercial technology transfer, and qualification studies related to bulk processes and pipeline vaccine bulk products.
• Actively participate on cross‑functional teams to advance project goals and deliverables related to vaccine processes or analytics.
• Lead technical, operational, and business system improvement projects.
• Provide SME knowledge for manufacturing investigations of product, process, and testing deviations.
• Occasionally provide off‑shift or weekend coverage to support the technical team based on project assignments or vaccine production schedules.

• Bachelor’s degree in Engineering, Science, or a related discipline with at least five (5) years of experience in vaccine or biologics manufacturing within an aseptic, cGMP environment, or a Master’s degree with at least three (3) years of experience, or a Ph.D. with relevant academic experience.
• Proven leadership and people‑management experience.
• Prior experience performing analytical assays (potency assays, serial dilutions, moisture testing, SDS‑Page, dry weight, UV‑Vis, BCA assay).
• Experience with analytical equipment such as SoloVPE, Lighthouse, Cedex Bio, ViCell, UPLC, plate readers, etc.
• Proficiency in statistical tools (JMP or Minitab) for experimental design, data analysis, and control chart trending.
• Experience in vaccine or biologics processing, including lab‑ or manufacturing‑scale support in analytics.
• Experience authoring technical documentation within a cGMP context.
• Strong technical communication skills (written and presentation).
• Strategic planning and management ability.
• Capacity to foster a collaborative work environment focused on mentorship, coaching, and SME development.
• Preferred: cGMP manufacturing or Quality Operations support, including immediate responses to deviations on the shop floor.
• Experience with Design of Experiments (DOE) and One Factor at a Time (OFAT) experimental design.
• Experience authoring technical documents supporting regulatory filings (IND, BLA).
• Experience with digital visualization tools (PowerBI, JMP, etc.).
• Ability to provide scientific mentorship and guidance to technical colleagues.

• Adaptability
• Adaptability
• Assay
• Biochemical assays
• Biopharmaceutical Industry
• Biopharmaceuticals
• Biopharmaceutics
• Change Control Processes
• Customer‑Oriented
• Deviation Management
• Engineering Standards
• Fast‑Paced Environments
• Good Manufacturing Practices (GMP)
• Maintenance Engineering
• Manufacturing Process Validation
• Mentor Coaching
• Mentorship
• People Management
• Pharmaceutical Biology
• Plan of Action and Milestones (POA&M)
• Process Characterization
• Proc…