Jee Look Email & Phone Number

Boyds, Md, Us

Gaithersburg, Maryland, Us

• Comprehensive CMC Strategy: Provided comprehensive CMC strategy from pre-clinical through licensure to post-marketing for Internal programs and CDMO client. Coordinated Drug Product Development Plans with multi-disciplinary teams, including Regulatory, Pre-clinical/Clinical, GMP Manufacturing, QA/QC, BD, and Legal to meet company objectives.• Team Building and Integration: Established a biologics drug product development team from scratch, capable of supporting CDMO clients and internal programs. Developed a business model to integrate Development team into CDMO business for gene and cell therapy. Successfully advanced two CDMO clients and one internal program to PPQ stages.• Funding Acquisition and Milestone Achievement: Secured $20 million in BARDA funding for the development of AV7909 commercial manufacturing process (Phase 3 PPQ) and $29 million in NIH funding for developing novel dry room temperature stable AV7909. • Advanced Formulation Technologies: Developed in-house dry stabilization technologies incorporating state-of-the-art lyophilization techniques (MicroFD, Revo® Pro, LyoStar 3-TDLAS), spray drying, and foam drying. Invented the first-of-its-kind formulation technology for lyophilizing alum-adjuvanted vaccines (Patent No: US 10 357 559 B2, Pub: Vaccine 37 (2019) 6356-6361).• Aseptic Formulation/Fill/Finish Processes: Developed novel nanoparticle aseptic manufacturing processes for mRNA-LNP, siRNA-peptide, mAb, ADC and suspension drug. Managed these processes from pre-clinical to early clinical and Phase 3 commercial scale (PPQ).• Drug Development Programs: Advanced 15 discovery programs to tox, phase I/II/III, including siRNA-peptide, Sudan mAb (CA45/FVM04), rPA vaccine, live virus vaccines (MVA-TB/-Flu/-Ebola [Phase I/II], VSV Lassa (Phase I). Three programs to phase 3’s PPQ (AV7909, Covid-mRNA-LNP, Conjugated protein) and one for licensure (Cyfendus®).• Financial and Team Management: Managed department financial forecasts and budgets.

• Transcutaneous Immunization Development: Led transcutaneous immunization drug delivery development including patch, micro-needle, micro-injector: ETEC vaccine (Ph I-III, & PPQ), Influenza (Ph 1), C. Difficile (Ph 1), Influenza (Ph 1), rPA (Ph 1) [Publication: Vaccine 30 (2012) 4349-4354]. • Patch Manufacturing Technology: Developed first of the kind GMP patch manufacturing technology for transcutaneous vaccines from proof of concept to Phase 3 (PPQ), focusing on dose sparing and traveler diarrhea ETEC vaccine (Publication: BioPharm Int, Volume 2007, Supplement, Issue 5, 34-45).• Immune modulator formulation: Invented novel nano particle delivery technology to modulate immune response of biologics, “IC31 Nanoparticle for adjuvant” (US Patent: 9,248,180 B2).

• Pneumococcal Glycoconjugate Vaccine Development: Developed the 2nd generation Pneumococcal glycoconjugate vaccine (13V Prevnar®) formulation and aseptic (F/F/F) manufacturing processes utilizing pre-filled syringes. Achieved a 5% increase in production output, generating an additional $50-$100 million in annual revenue. Resolved visible particulate and stability issues due to device changes in Phase 3, enabling progression to PPQ and licensure (US Patent 7,935,787 B2 and Patent app AU2007/243019 A1).• Aseptic Live Virus Vaccine Manufacturing (2nd Gen FluMist®): Developed aseptic live virus commercial scale F/F/F processes for intra-nasal Cold Adapted live Influenza Virus Vaccine (2nd generation FluMist®) and obtained licensure. Led multidisciplinary teams (DEV/REG/QA/Manufacturing/Supply Chain) to successfully transfer technology to GMP manufacturing sites for PPQ.• Innovative Live Virus Vaccine Formulations: Invented a stabilized intra-nasal vaccine for Cold Adapted live virus RSV/PIV (US Patent 8,603,796 B2). Developed formulations for bacterial Meningococcal B (MnB) and Group A Strep vaccines, advancing them to toxicology studies and Phase I clinical trials, with MnB later licensed as "Trumenba®".

• New Technology Development for OTC Products: Engaged in the development of new technologies for over the counter (OTC) products. Invented a fast-dissolving tablet technology for small molecular drugs using a solid-solution approach, resulting in US Patent 6,733,781 B2. Developed the first-of-its-kind two-color lip balm product and the corresponding manufacturing technologies (US Patent series: 6,699,510 and USD454664 S1). • Consumer Study: Created various conceptual products for marketing evaluation, including an edible film-containing drug, gel cooling patches for hemorrhoids, and Chapstick. Conducted cost and financial analysis for new technologies and their manufacturing processes. • Technology Transfer Management: Managed third-party technology transfers to enhance the company’s in-house manufacturing capabilities for tablet technology in spray drying, twin-screw extrusion, supercritical fluid processing, melt granulation, and fluid bed coating.

Cincinnati, Ohio, Us

• Nanoparticle Capability Development for Cosmetic: Built new in-house nanoparticle capabilities in dry/wet milling, coating, and encapsulation for cosmetic products. Invented a novel nanoparticle processing technology for nail polish (PCT patent app: WO1999055292 A1).• Consumer Study: Created various conceptual products for marketing evaluation, including focus group product assessments in a global market setting.

Oak Ridge, Tn, Us

• Advanced Materials for Semiconductors: Conducted nanoparticle research for advanced materials for semiconductors. Invented hollow nanoparticle manufacturing technology for use in multilayer semiconductor chips (US Patent 5,492,870).• Nanoparticle Separation Research: Performed separation research for nanoparticles using electrical fields. Submitted four disclosures to the US Department of Energy (DOE).

• Nanoparticle Synthesis Lab Setup: Led the production of uniform powders for advanced materials applications.Established a sol-gel powder synthesis laboratory. • Semiconductor Substrate Research: Successfully identified factors causing inconsistent suspension stability in multilayer semiconductor substrates used in supercomputer chips. Resulted in a processing patent application in Japan.

Ph.D, Chemical Engineering (Nanotechnology/Material Science/Colloidal Science)

Master Of Science - Ms, Semiconductor Manufacturing Technology (Plasma Etching Of Silicon Wafer)

Mba, Finance

Bsc, Chemical Engineering