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• Initiated guidance program for best communications practices and message framing enhancement to reduce bottom-up/top-down decision-making churn• Drove increased processing flexibility initiatives within working teams to drive continuous improvement through TTs• Technical process lead for CMO selection committees• Technical SME for all filler isolator technical standards and global guidelines• Technical SME for all filling CMO processes for agency submissions and communications• Represented global engineering as the biophorum co-author for DP workstreams• Led assessments of Annex 1 and filling operations observations

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•Led process validation for final sterile product filled vial manufacturing PPQ and other necessary validation activities•Managed global DP activities across multiple network facilities including site GMP readiness •QRM facilitator and SME for cross functional risk assessments for process failure modes, site multi product/modal manufacturing, facility fit and process gap, and cross contamination mitigation •Onboarded additional vial size capabilities and modular gene therapy DP manufacturing platform•Implemented process data PPK charting to improve parameter control during vial production•Process investigation lead for post-production quality events and deviations•Authored development studies, technical reports, engineering test protocols, execution protocols, facility fits, and risk reports

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 functionality issues and maintain a good public image

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•Submitted and received grant funding for active projects

•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