Catherine Wagner Email & Phone Number

Durham, North Carolina, United States

Led Operations team through Engineering Runs, resolving shop floor issues quickly and safely. Drove completion of successful environmental monitoring performance qualification, collaborating across departments to close critical prerequisites; ensured suite integration was performed effectively and compliantly. Drove development of Operations team strategy: Created and maintained team schedule for validation runs, filling gap until scheduler was hired. Proposed and implemented staffing plan to bridge transition to 24/7 shift coverage. Led team through first shop floor activities, ensuring critical work was performed safely and successfully.

Oss, North Brabant, Netherlands

Provided Technical Operations Product Support for key cancer treatment and fertility products. Led project to build & operationalize first internal working cell bank long-term storage node in Europe, coordinating stakeholders across capital projects, operations, engineering, validation, quality, and regulatory. Upskilled in data analytics by building an automated data visualization dashboard for proactive process data review.

Philadelphia, Pennsylvania, United States

Contributed to key vaccines expansion case as a member of the External Manufacturing Vaccines Drug Substance Technical Team. Supported tech transfer and aligned with internal and external stakeholders to ensure completion of engineering batches and successful start of process performance qualification. Provided technical shift support at external partner in Vienna, Austria, collaborating effectively across companies and languages to respond quickly to shop floor needs. Served as team lead for new change system; stepped in to hypercare time-critical change controls as needed.

Elkton, Virginia, United States

Worked on the Process Robustness team supporting drug substance purification technical operations. Contributed to 2021 drug substance yield improvement of ~10%. Evaluated process sampling & advocated to streamline samples, saving ~190k doses. Supported creation of digital dashboard to track and highlight waste reduction opportunities.

Durham, North Carolina

Merck (Organon Teknika Corporation), Durham, NC Researched and proposed new harvest collection container for life-saving bladder cancer treatment manufacturing process. Ensured product compatibility with current aseptic manufacturing process and improved container closure integrity. Contributed to site readiness for future increased throughput by ~3000 vials per batch, critical to meet growing market demand. Analyzed manufacturing site process capability with JMP software. Utilized results to understand sources and degree of variation of critical quality attributes. Evaluated process/product impact in process capability report.

Raleigh-Durham, North Carolina Area

Designed and executed experiments to model polystyrene folding in response to IR/LED stimuli, resulting in publication:Mailen, R.W., Wagner, C.H., Bang, R.S., Zikry, M., Dickey, M.D. & Genzer, J. "Thermo-mechanical transformation of shape memory polymers from initially flat discs to bowls and saddles." Smart Materials and Structures, vol. 28, no. 4, 2019, pp. 1-10.Collaborated with cross-disciplinary team to analyze results and applications. Developed valuable critical thinking and presentation skills. Funding provided by National Science Foundation Emerging Frontiers in Research and Innovation (EFRI) program.

Raleigh-Durham, North Carolina Area

Encouraged weekly development of students' mathematics and chemistry skills by tailoring tutoring techniques to each student's individual learning style.

Bachelor Of Arts (B.A.), Spanish Language And Literature

Activities and Societies: Phi Beta Kappa, Sigma Delta Pi

Bachelor Of Science (B.S.), Chemical Engineering

Activities and Societies: Tau Beta Pi, Alpha Omega Epsilon Professional Engineering Sorority