Experience

Arcus Biosciences

• United States
• Biotechnology
• 300 - 400 Employee

• Senior Director, Head of Small Molecule Pharmaceutical Development and Mfg. at Arcus Biosciences

  • Oct 2023 - Present

  Hayward, California, United States

• Director, Small Molecule Drug Product Development and Manufacturing

  • Jun 2021 - Oct 2023

  Hayward, California, United States



Amgen

• United States
• Biotechnology Research
• 700 & Above Employee

• Principal Scientist, Drug Product Process Development

  • Jun 2019 - 2021

  Thousand Oaks Managerial and Technical Responsibilities: • Leading multiple programs covering activities from formulation development, process characterization, scale-up, validation, authoring IND/NDA CMC sections/RTQs, commercial process improvements, post-approval commitments/ changes (SUPAC) to commercial product support • Substantial technical and management leadership experience for commercial advancement of programs from early development to commercialization • Robust experience in developing… Show more Managerial and Technical Responsibilities: • Leading multiple programs covering activities from formulation development, process characterization, scale-up, validation, authoring IND/NDA CMC sections/RTQs, commercial process improvements, post-approval commitments/ changes (SUPAC) to commercial product support • Substantial technical and management leadership experience for commercial advancement of programs from early development to commercialization • Robust experience in developing manufacturing strategies, resolving formulation and technical manufacturing challenges and building new avenues to retain market exclusivity of legacy products via life cycle management strategies • Proven track record of moving drug candidates from Phase 1 through Phase 3 and commercialization with solid understanding of all facets and phases of CMC drug development for solid/liquid oral dosage forms to parenteral drug products include Mimpara® (capsule), Corlanor® (sterile liquid in blow fill seal vial), AMG-510 (tablet) and AMG-176 (sterile liquid in vial) • Leading multiple CMC teams to develop robust cross-functional product strategy incorporating drug substance, clinical development, analytical/attribute sciences, regulatory, commercial, and operations considerations • Strong understanding of global regulatory requirements for drug products. Authored CMC sections for IND, IMPD, and NDA for global MA filing • Core team member of Amgen due diligence team in the selection process for external CDMO partners to develop and commercialize Amgen products • Representing Amgen in IQ Pediatric Drug Product Leadership Group (IQ-DPLG) to develop and implement evolving pediatric formulation and regulatory strategies among pharmaceutical industries and regulatory agencies

• Senior Scientist, Drug Product Process Development

  • Jan 2014 - Jun 2019

  Thousand Oaks, California



Impax Laboratories

• Pharmaceutical Manufacturing
• 200 - 300 Employee

• Research Scientist-II, Brand Product Development

  • Oct 2008 - Jan 2014

  Hayward, CA • Team member to develop and commercialize Rytary®, a highly complex multi-component (multiparticulates) extended release Carbidopa-Levodopa capsule formulation to treat Parkinson’s disease • Drug product technical lead for IPX-159 program: Developed extended release Nefopam tablet formulation to treat restless leg syndrome (RLS) from early stage to late stage. Manufactured Ph-I to II clinical batches to support clinical studies as well as process characterization and scale-up studies •… Show more • Team member to develop and commercialize Rytary®, a highly complex multi-component (multiparticulates) extended release Carbidopa-Levodopa capsule formulation to treat Parkinson’s disease • Drug product technical lead for IPX-159 program: Developed extended release Nefopam tablet formulation to treat restless leg syndrome (RLS) from early stage to late stage. Manufactured Ph-I to II clinical batches to support clinical studies as well as process characterization and scale-up studies • Drug product technical lead for IPX-237 program: Developed drug abuse deterrent sub-lingual lipid-based Ketamine formulation to treat depression. Patent is filed for novel formulation technology to deter drug-abuse (WO2015051259A1) • Drug product technical lead for IPX-632 program: Developed extended release tablet formulation for highly insoluble Tetrabenazine compound using enabling technologies such as hot-melt extrusion and spray drying technologies to treat Tourette’s syndrome • Authored IND/NDA CMC sections for various drug products covering extended release capsule and tablet formulations to drug abuse deterrent sub-lingual formulations • Robust experience of developing various drug products and processes which include preparation of FIH formulations, excipient compatibility studies, thermal stability studies, in-vitro dissolution studies, DSC, SEM, granulation, blending, milling, extrusion, spheronization, and coating (aqueous and organic) • Chaired a life cycle management team to provide brand protection IP strategies to prolong drug product market exclusivity and grow research pipeline • Served as primary interface between process development, analytical, quality, supply chain and regulatory organizations for end to end product development activities Show less