David Walser Email & Phone Number

Raleigh, Nc, Us

Durham, North Carolina, United States

• Lead Subject Matter Expert (SME) and process owner for technology transfer of drug product stabilizer preparation and pooling • Design and execute supporting process studies on material charges, filtration, and mixing• Create over 30 process diagrams to guide electronic documentation and automation recipe development• Facilitate cross-functional team meetings to drive process development and optimize efficiency• Provide on-the-floor and on0call technical support on both nights and days to ensure safe, right first time manufacturing• Support global knowledge share via regular presentations within the Media and Buffer Community of Practice (CoP)• Drive cross-site coordination in the area of Diversity, Equity, and Inclusion as the site representative to the Large Molecule Technical Operations organization• Saved over a hundred thousand dollars by optimizing media usage by matrixing study parameters for technical studies• Organized and led over half a dozen presentations and training sessions to upskill operators and colleagues on the pooling process• Investigated and implemented CAPAs for near miss safety incident while working closely with EHS counterparts and above-site SMEs

Durham, North Carolina, United States

• Lead and successfully execute multiple shakedown runs for pre-culture stage of drug substance biomanufacturing• Work alongside Quality Assurance, Operations, and Automation teams to ensure PPQ readiness• Author batch record procedures for cell pre-culture, exceeding 200 pages• Train over a dozen Operation technicians on manufacturing processes and equipment• Redline and edit process batch records, SOPs, and forms to align with cGMP• Provide upstream processing technical support from cell inoculation to production bioreactors• Support analytical equipment process qualification and bioreactor control studies

Durham, North Carolina, United States

• Authored batch records, single-use diagrams, and material lists for upstream biomanufacturing of drug substances• Trained Operation coaches and technicians on manufacturing processes and equipment• Wrote and executed technical protocols on quantifying mixing rates and media hold up for process execution• Redlined and edited documentation, including process batch records, SOPs, and forms, to align with cGMP• Provided upstream processing technical support from cell inoculation to production bioreactors• Led waste-to-drain assessment for low bioburden biomanufacturing• Executed water and shakedown runs for culturing of adhesive cell lines

Raleigh-Durham, North Carolina Area

Undergraduate Student Employee enrolled in the Provost’s Professional Experience Program (PEP)• Conduct self-led research project on detection of heavy metals in water sampling• Support ongoing NC State extension project on the effect of prebiotics on fish development • Assist graduate student research on biofiltration media for aquacultural systems

Raleigh-Durham, North Carolina Area

Undergraduate Student Employee working for the University Sustainability Office• Develop strategies and materials for sustainability outreach • Conduct awareness training for student organization officers• Act as a sustainability liaison for sustainability programs, campus units, and student leaders

Franklinton, North Carolina Area

• Developed and executed experiments to optimize fermentation and dosing media for over a dozen products• Investigated and validated new instrumentation later adopted by Environmental Operations• Gained hands-on experience with state-of-the-art laboratory instrumentation and bioreactors

Raleigh-Durham, North Carolina Area

• Learned sustainable agricultural practices and developed skills needed to operate an urban farm and community garden• Led volunteers of different ages, ethnicities, ability, and backgrounds• Networked with small-business owners engaged in local food production

Bachelor Of Science - Bs, Biological/Biosystems Engineering, Senior

Activities and Societies: NC State Stewards Delta Phi Alpha (German Honor Society) Engineers Without Borders American Society.

Education record