David Hight Email & Phone Number

Raleigh, NC, US

Melbourne, Victoria, AU

• Process owner and lead for all DP activities including vial filling, sterile boundary manufacturing, and visual inspection at multiple CMOs
• Drove $30M+ recurring yield and operations excellence improvements across network CMO activities for both early and late LCM programs
• Initiated and implemented large scale cross-functional product quality enhancement programs
• Provided key processing insights for top-down portfolio executive management decision-making
• Technology owner for CMO FAT, SAT, and PQ activities for line modifications
• Led multiple strategic changes to transferring processes to reduce program and timeline risk

San Diego, CA, US

• Process leader for all DP activities including vial filling, sterile boundary manufacturing, visual inspection, and labeling at multiple network facilities
• Client manager for all DP technical process development and implementation activities
• Developed and managed multiple site Aseptic Process Simulation programs including fixed and matrix approaches
• Audit SME for all sitewide fill finish activities, APS, filter validation, and CCIT
• Led tech transfers for multiple phase 1 drug production runs from cell expansion through labeling as both technical lead and project manager including DP CMC development
• Oversaw development for team members focusing on DP manufacturing buildout

Somerville, Massachusetts, US

• Co-authored and developed Filling and Final Filtration Aseptic Process Simulation protocol and drove execution. Assisted in program design, exception writing, and action implementation
• Acted as primary center of information and SME between manufacturing, quality, and engineering for filling operations. Assisted in troubleshooting of Skan Isolator as needed
• Owned change controls and executed actions for needed cGMP compliance in filling process
• Facilitated and performed risk assessment as functional area lead with cross-functional team for aseptic filling interventions and participated in authorship and review of final risk report

Somerville, Massachusetts, US

• Authored Standard Operating Procedures and On the Job Trainings for Filling, Upstream, and Downstream operations pre and post GMP production
• Edited, reviewed, and approved SOPs, OJTs, Quality Events, and Process Improvements
• Investigated, developed, and implemented improvements to cell expansion, filling, and downstream procedures
• Developed all filling and autoclave operations, OJTs, and SOPs for aseptic vial filling supporting 24/7 activities
• Initiated necessary deviations and implemented change and preventative actions to ensure appropriate responses.

Somerville, Massachusetts, US

• Executed aseptic batch cell expansion and viral vector product manufacturing
• Performed engineering runs for process development including USP, DSP, and Fill Finish. Initiated needed changes for cGMP compliance and implemented corrective actions
• Initiated necessary deviations and CAPAs
• Performed and oversaw safety audits and GDP record conformance

• Organized and implemented in-depth technical repairs of all Autochem instrumentation as well as new sale manufacturing
• Completed technology transfer of new particle view and Raman instruments to US based manufacturing facility
• Attended manufacturing build seminars to assist with instrument process design and development from a high-level service perspective
• Initiated changes to general manufacturing procedures based on quality control conclusions derived through root-cause analysis and chemical compatibility testing. Additionally, oversaw warranty programs to repair known.

Raleigh, North Carolina, US

• Co-authored peer reviewed publication in Physical Review Letters for discovery of novel fractal instabilities in liquid metals driven through controllable electrochemical oxidation
• Studied the properties and dynamics of the surface chemistry of liquid metals with team
• Led and assisted analysis technique development such as ellipsometry, GC, HPLC, and XPS
• Managed and taught intern students to assist with projects studying fundamental effects of electrical stimulus on liquid metals throughout the summer and school year
• Peer reviewed submitted publications across various academic journals
• Developed custom computational programs to assist in analytical techniques and video analysis

• Designed a marketable IoT device by working under the advisement of various entrepreneurs and other engineering investors in a team of cross-functional engineers
• Studied and developed marketing campaign to examine the technology’s potential in real world markets through customer communication and testing
• Attained corporate sponsorship from Plexus and Ayla Networking for prototype development.
• Integrated IoT technology into a build prototype to demonstrate proof of concept

Bachelor Of Science (Bs), Chemical Engineering: Nanoscience Concentration

Master Of Science (M.S.), Chemical Engineering