Daniel Liu Email & Phone Number

Chicago, Il, Us

Chicago, Il, Us

Work on complex generic drug formulation including liposome and lipid nanoparticles.Well-versed in modern analytical techniques and methods, and have a passion for utilizing my skills to advance the development of safe and effective drugs.Adhering to GMP guidelines, have successfully developed and validated various analytical methods such as LCMS, HPLC and drug impurity synthesis, providing reliable data for the characterization and analysis of drug products.Deep understanding of extractable and leachable analysis, peptide drug high order structure, and their significance in the overall safety and efficacy of drug products.As a seasoned professional in the field of biosimilar development, have expertise in performing similarity analysis and developing generic drugs to RLD standards.Have a proven track record of resolution of deficiency letters, ensuring seamless drug approval process.

• Assist in manufacture of Pfizer-BioNtech Covid-19 vaccine• Routine practice of and compliance with GMP/GLP and Good Documentation Practice• Execute method development and qualification under FDA regulatory perspective.• Author technical protocols, reports and test methods for raw materials, APIs, excipients, drug products• Work with manufactures to diagnose the production problems, make improvements of processes, enable success of technology transfer, and enhance product performance. • Generate documentation, including but not limited to protocols, reports, work instructions and investigations.• Performs root-cause analysis and identifies and implements effective corrective and preventive actions (CAPA) • Communicate effectively with internal and external collaborators (Business management, Engineering, Maintenance, QA/QC, Validation, EHS) to achieve project objectives.• Knowledge with manufacturing unit operations for liposomal drug production (ultrafiltration, diafiltration, freeze drying, mixing and sterile filtration)• Perform testing and data review for HPLC/UPLC (IEX, SEC, IPRP, etc.), GC, CE, ELISA FTIR, UV-Vis and physicochemical properties (pH, particle size, zeta potential, osmolality, etc.) on lipid nanoparticle products (cargos include chemical molecules, biological molecules like proteins, nucleic acids and vaccines)• Expertise with nucleic acid (siRNA, mRNA, gRNA, saRNA), protein and lipid chemistry

Columbus, Ohio, Us

• Hands-on experience in designing, optimizing, and characterizing nanoparticles formulations (lipid, polymer, or hybrid) for small molecules, NAs, and proteins.• Familiarity with lab-scale nanoparticles preparation techniques (solvent injection, film-hydration, microfluidics, peristaltic pumps)• Experience with alternate pharmaceutical manufacturing technologies homogenization (Avestin Emulsiflex), lyophilization (Labconco), high intensity sonication, tangential flow filtration and extrusion. • Develop bioconjugation approaches for target delivery, including peptides, mAbs, folic acid on liposomes.• Synthesize novel functional agents, such as functional lipids, modified proteins, transfection agents for novel delivery applications.• Prepare, process, purify and characterize novel protein-drug conjugates.• Perform in vitro and in vivo evaluations on novel drug formulations.• Synthesize novel pro-drugs and develop suitable formulations.• Manage lab instrument (HPLC, UV, DLS, Extruder, TFF, Homogenizer, Lyophilizer), including maintenance, troubleshooting, repair, training and provide synthetic, analytical and process development supports.• Participate in the preparation of lipid-coated albumin nanoparticles encapsulated with antisense oligonucleotides; prepare GLP grade product and generate SOPs on process development activities. • Involved in OSU’s largest license of its microRNA technologies to Microlin Bio.• Receive Graduate Fellowship (PK/PD) from Eli Lilly and perform PK animal study on my own developed drug.

• Constructed cryobiological systems by low-temperature DSC and osmometer. • Investigated lipid changes in oocytes during cryopreservation using HPLC, TLC and MALDI-TOF MS.

Doctor Of Philosophy - Phd, Pharmaceutics (Nanoparticle Formulation And Pharmacokinetics)

Master'S Degree, Organic Chemistry