Senior Specialist, Process Support Lab

About the role

The Maurice R. Hilleman Center for Vaccine Manufacturing, located in Durham, NC, is seeking a Senior Specialist with outstanding interpersonal, communication, and collaboration skills. The PSL Senior Specialist will be responsible for managing a team of scientists and engineers who lead analytical projects.

Responsibilities

• Manage PSL study leads on the team, specifically analytics team.
• Serve as a team Subject Matter Expert (SME) in technical data analysis.
• Leverage these skills to serve as a mentor in up-skilling and supporting peers in statistical tool and graphing techniques for experimental design, analysis, and process monitoring of manufacturing and Quality Operations testing, as needed.
• Provide technical review and/or approval of PSL team experimental design proposals, analysis, technical protocols and reports.
• Leverage various technical background (upstream, downstream, drug product, analytical) to lead and support late-stage process development, scale-down model development/execution/implementation, process characterization, commercial technology transfer, and qualification studies.
• Support workstreams 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 qualifications or trouble-shooting of in-process assays in the tech transfer and manufacturing spaces.
• Execute experimental studies as needed for investigational, developmental, or continuous improvement projects for our Company's existing Durham vaccine products.
• Lead technical, operational, and business system improvement projects.
• Provide SME knowledge for manufacturing investigations (Product, process, and testing deviations).

Qualifications

• Required: Bachelor's degree in Engineering, Science or related discipline with a minimum of five (5) years of required experience in vaccine or biologics manufacturing within an aseptic, cGMP environment, OR Master's degree with a minimum of three (3) years of required experience OR Ph.D. with relevant academic experience.
• Prior experience performing analytical assays (i.e. potency assays, serial dilutions, moisture testing, SDS-Page, dry weight, UV-Vis, BCA Assay).
• Prior experience with any of the following equipment ex: SoloVPE, Lighthouse, Cedex Bio, ViCell, UPLC, plate readers etc.
• Proficient using statistical tools (JMP or Minitab) for experimental design, data analysis and control chart trending.
• Experience in vaccine or biologics processing, including either lab- or manufacturing-scale support in analytics.
• Experience authoring technical documentation within a cGMP context.
• Proven technical communication (written & presentation) skills.
• Strategic plan development and management.
• Ability to foster a collaborative work environment focused on mentorship, coaching, and Subject Matter Expert development.

Preferred

• cGMP manufacturing or Quality Operations support including providing immediate responses on the shop floor to deviations and potential deviations.
• Ability to drive studies and experiments in the context of a long-term commercialization plan.
• Design of Experiment (DOE) and One Factor at a Time (OFAT) experimental design.
• Experience authoring technical documents supporting regulatory filings (IND, BLA).
• Experience using digital visualization tools (PowerBI, JMP, etc.).
• Ability to provide scientific mentorship and guidance to technical colleagues.