Daniel Rodriguez-Granrose, Phd, Psm Email & Phone Number

Salt Lake City, UT, US

Salt Lake City, Utah, United States

• Built novel intact tissues, drug substance, drug product, process and tissue bioreactors, process controls, and analytical methods (patent pending)

• Lead multifunctional stakeholders on the most efficient path to advance/de-risk CMC
• Leveraged in-depth knowledge of ICH guidelines to write/transfer regulatory filings
• Aided multiple groups in technical bioprocess development, management, and purchasing decisions.

• Lead bioprocess development; define, document, characterize, and ensure comparability between scales for the IDCT production process using a Quality by Design approach
• Lead Phase I Process Validation and ensure regulatory compliance of the IDCT bioprocess by leading cross-functional Chemistry, Manufacturing, and Controls working group

Salt Lake City

• Devised and formally directed Quality by Design (QbD) bioprocess characterization, chemistry, manufacturing, and controls, including scientific rationale, >$2 mil budget, timeline, PD team (6.5 FTE), regulatory.
• Drove bioinformatics intensive development with novel Design of Experiments (DOE), Artificial Intelligence, computational fluid dynamics, QbD, tissue culture, and bioprocess solutions

Salt Lake City

• Devised, executed, and analyzed “custom DOE” using attachment culture systems, stirred tank reactors, and JMP—accounting for variation between genetically distinct allogeneic cell lineages using true multi-dimensional.
• Developed scalable cell spheroid bioprocess from primary tissue to formulated cell therapy candidate as lead bioprocess scientist with 3 direct reports

Athens, GA

• Led bioprocess development for highest priority project; designed, operated, and optimized mammalian, insect, and viral processes from bench to industrial scale, ran 100s of bioreactors
• Trained and led PhD level scientists on upstream and downstream processes as study director for 9 unique projects
• Transferred successful processes from R&D to manufacturing

Athens, GA

• Designed and refined bioprocesses for Department of Homeland Security
• Planned and carried out upstream and downstream mammalian-ad5 bioreactor studies

• Worked on mammalian cell culture and biofuel projects with industry partners at pilot scale bioprocess plant
• Investigated the molecular basis of bacterial type II secretion using diverse genetic engineering techniques including plasmid, protein, and genetic network design
• Selected from nationwide competition to conduct a 3-month, forensic phylobiology research study across China, Taiwan, and Japan as National Science Foundation Partners in International Research and Education Fellow

Phd In Biochemistry And Molecular Biology

Professional Science Masters, (Track: Biopharma Management And Regulatory Affairs)

Received business training through the Terry Professional MBA program and regulatory affairs training through the UGA College of Pharmacy..

Bachelor Of Science, Applied Biotechnology

Activities and Societies: Named UGA’s Amazing Student in Biotechnology 2013 Recognized as Presidential Scholar & placed on the Dean’s List.