Experience

Assembly Biosciences, Inc.

• United States
• Biotechnology Research
• 1 - 100 Employee

• Chief Manufacturing Officer

  • Feb 2022 - Present

  South San Francisco, California, United States

• SVP, Pharmaceutical Development & Manufacturing

  • Nov 2020 - Feb 2022



Gossamer Bio

• United States
• Biotechnology Research
• 100 - 200 Employee

• Senior Director & Head of Process Chemistry

  • Sep 2019 - Nov 2020

  • Joined Gossamer as one of the first CMC employees and was instrumental in building the CMC organization. • Led a team of 10 process chemists based globally, that substantially reduced the drug substance cost of goods by >70% across the Gossamer portfolio. • CMC program lead for two programs in development and mentored three direct reports as CMC leads. As CMC lead ensured alignment of activities across all CMC departments and responsible for communication of CMC goals and… Show more • Joined Gossamer as one of the first CMC employees and was instrumental in building the CMC organization. • Led a team of 10 process chemists based globally, that substantially reduced the drug substance cost of goods by >70% across the Gossamer portfolio. • CMC program lead for two programs in development and mentored three direct reports as CMC leads. As CMC lead ensured alignment of activities across all CMC departments and responsible for communication of CMC goals and deliverables to the executive team. • Responsible for the drug substance supply across seven programs that included four clinical compounds (Ph1 to Late-Ph2) and three preclinical compounds. • In depth knowledge of the ICH guidelines and phase appropriate regulatory strategies to ensure product quality and flexibility of supply chain. Authored CMC sections of regulatory documents including INDs, IMPDs, Briefing Books and IBs. Drafted responses to regulatory authority questions and participated in meetings with EU & US regulatory authorities. • Served as a CMC subject matter expert in Gossamer diligence for programs in a variety of therapeutic areas. • Experienced with development of spray dried dispersions, solid oral dosage formulation development (tablets & capsules) and development of inhalation formulations including nebulized and dry powder formulations. • Led strategic planning and stockpiling of key raw materials for drug substance & devices across the Gossamer portfolio that led to no disruption in clinical supply due to COVID Publications: 1. Asselin, Sylvie; White, N.; Flahive, E.; Winnike R.; Marsini, M. “Crystalline salt forms of (z)-4-(5-((3-benzyl-4-oxo-2-thioxothiazolidin-5-ylidene)methyl)furan-2-yl)benzoic acid” U.S. Patent WO20211096988, May 20, 2021.

• Director Process Chemistry

  • May 2018 - Sep 2019

  Greater San Diego Area



Abide Therapeutics

• Director CMC

  • Jan 2017 - Apr 2018

  San Diego, California • Responsible for providing CMC updates in Board Meetings and Scientific Advisory Board Meetings. • Developed and implemented strategies for progression of preclinical compounds into Ph1 in <12 months and progression of ABX-1431 into Ph2 clinical trials • Led process chemistry for compounds under development and conducted route optimization to deliver non-GMP & GMP material on multi-kilogram scale. Publications: 4. Grice, Cheryl; Buzard, D. J.; Shaghafi, M.; White, N.;… Show more • Responsible for providing CMC updates in Board Meetings and Scientific Advisory Board Meetings. • Developed and implemented strategies for progression of preclinical compounds into Ph1 in <12 months and progression of ABX-1431 into Ph2 clinical trials • Led process chemistry for compounds under development and conducted route optimization to deliver non-GMP & GMP material on multi-kilogram scale. Publications: 4. Grice, Cheryl; Buzard, D. J.; Shaghafi, M.; White, N.; Lopez, H.; Therkelsen, D.; Knudsen, B. “Crystalline forms of a MAGL inhibitor” U.S. Patent WO2021097107, May 20, 2021. 3. Lianfeng, H.; Tsou, N.; White, N.; Xu J.; Zhang, Q. “Crystal polymorphs of (R)-5-carbamoylpyridin-3-yl-2-methyl-4-(3-(trifluoromethoxy)benzyl)piperazine-1-carboxylate for use in prevention and/or treatment of pain, neurological disorders, anxiety, inflammatory bowel disease, neuropathic pain and cancer,” U.S. Patent WO20200516105, March 19, 2020. 2. Grice, C.; White, N.; Zingerman, J.; Terefe, H.; Ghebre-Sellassie, I. “Pharmaceutical formulations comprising monoacylglycerol lipase inhibitor and use thereof,” U.S. Patent WO2018093950, May 24, 2018. 1. Grice, C.; Hertzog, D.; Buzard, D.; White, N. “Preparation of piperazine carbamate derivatives as MAGL inhibitors for the treatment of pain and other diseases,” U.S. Patent US20180134675, May 17, 2018.

• Associate Director Process Chemistry

  • Oct 2015 - Jan 2017

  San Diego, California



Gilead Sciences

• United States
• Biotechnology Research
• 700 & Above Employee

• Senior Manager Chemical Development and Manufacturing

  • Apr 2013 - Oct 2015

  • Led a team of three people and contributed to programs through all stages of development from pre-clinical through commercialization, specifically the Ledipasvir (Harvoni®, HCV cure), Tenofovir Alafenamide (Vemlidy®, HBV treatment) and Voxilaprevir (Vosevi®, HCV cure) programs. • Was a member of the core scientific team on the Harvoni® Hepatitis C cure program and played a key role in the NDA enabling activities and supply strategy for commercial launch. • Was the chemical outsourcing… Show more • Led a team of three people and contributed to programs through all stages of development from pre-clinical through commercialization, specifically the Ledipasvir (Harvoni®, HCV cure), Tenofovir Alafenamide (Vemlidy®, HBV treatment) and Voxilaprevir (Vosevi®, HCV cure) programs. • Was a member of the core scientific team on the Harvoni® Hepatitis C cure program and played a key role in the NDA enabling activities and supply strategy for commercial launch. • Was the chemical outsourcing lead for a fast-tracked Hepatitis C program Voxilaprevir (Vosevi®) that was manufactured by a 15+ step synthetic route. Managed over 20 CMOs to support this program and ensured drug substance supply on multi-kilogram scale. • Was a member of the Tenofovir Alafenamide corporate alliance team representing Gilead in partnerships with external companies. Publications: 1. Colby, Denise A.; Martins, A.; Roberts, B; Scott, R.; White, N. “Methods for preparing anti-viral nucleotide analogs,” U.S. Patent US9676804B2, Jun 13, 2017.

• Research Scientist II Process Chemistry

  • Feb 2012 - Apr 2013

• Research Scientist I Process Chemistry

  • Mar 2009 - Feb 2012



UC Irvine

• United States
• Higher Education
• 700 & Above Employee

• Graduate Student

  • Sep 2004 - Mar 2009

  • Synthesized the tetracyclic core of the complex pyrrole-imidazole alkaloid massadine. • Completed the synthesis of the hexacyclic palau'amine core and provided evidence supporting the structural reassignment. • Developed a reaction methodology for the catalytic asymmetric synthesis of allylic aryl ethers. Publications: 4. Cannon, J. S.; Olson A.; Overman, L. E.; White, N. "Palladium(II)-Catalyzed Enantioselective Synthesis of 2-Vinyl Oxygen Heterocycles," J. Org. Chem. 2012… Show more • Synthesized the tetracyclic core of the complex pyrrole-imidazole alkaloid massadine. • Completed the synthesis of the hexacyclic palau'amine core and provided evidence supporting the structural reassignment. • Developed a reaction methodology for the catalytic asymmetric synthesis of allylic aryl ethers. Publications: 4. Cannon, J. S.; Olson A.; Overman, L. E.; White, N. "Palladium(II)-Catalyzed Enantioselective Synthesis of 2-Vinyl Oxygen Heterocycles," J. Org. Chem. 2012, 77, 1961–1973. 3. Lanman, B. A.; Overman, L. E.; Paulini, R.; White, N. "On the Structure of Palau’amine: Evidence for the Revised Relative Configuration from Chemical Synthesis," J. Am. Chem. Soc. 2007, 129, 12896–12900. 2. Kirsch, S.; Overman, L. E.; White, N. "Catalytic Asymmetric Synthesis of Allylic Aryl Ethers", Org. Lett. 2007, 9, 911–913. 1. Anderson, C. E.; Overman, L. E.; Richards, C. J.; Watson, M. P.; White, N. "Preparation of (5-(S)-2-(4-Methylethyl)-oxazolinylcyclopentadienyl)-(4-1,3-cyclobutadiene-1,2,3,4-tetrayl)tetrakis[benzene]][1,2,3,4,5-)-1-[(4S)-4,5-dihydro-4-(1-methylethyl)-2-oxazolyl]-2-4-cyclopentadien-1-yl])," Org. Synth. 2007, 84, 139–147. Show less



Neurocrine Biosciences

• United States
• Biotechnology Research
• 700 & Above Employee

• Research Associate Medicinal Chemistry

  • Sep 2002 - Sep 2004

  • Gained experience with drug-design issues, including receptor binding affinity, structure-activity relationships, P450 liver enzyme inhibition, relative lipophilicity of a molecule and the ability of a molecule to penetrate the blood-brain barrier. Publications: 8. Chen, C. W.; Tran, J.; Jiang, W.; Tucci, F.; Arellano, M.; Wen, J.; Fleck, B.; Marinkovic, D.; White, N.; Pontillo, J.; Saunders, J.; Madan, A.; Foster, A.; Chen, C. Bioorg. Med. Chem. Lett. 2006, 16, 4800–4803. 7.… Show more • Gained experience with drug-design issues, including receptor binding affinity, structure-activity relationships, P450 liver enzyme inhibition, relative lipophilicity of a molecule and the ability of a molecule to penetrate the blood-brain barrier. Publications: 8. Chen, C. W.; Tran, J.; Jiang, W.; Tucci, F.; Arellano, M.; Wen, J.; Fleck, B.; Marinkovic, D.; White, N.; Pontillo, J.; Saunders, J.; Madan, A.; Foster, A.; Chen, C. Bioorg. Med. Chem. Lett. 2006, 16, 4800–4803. 7. Jiang, W.; Tucci, F.; Chen, C.; Arellano, M.; Tran, J.; White, N.; Marinkovic, D.; Pontillo, J.; Fleck, B.; Wen, J.; Saunders, J.; Madan, A.; Foster, A.; Chen, C. Bioorg. Med. Chem. Lett. 2006, 16, 4674–4678. 6. Pontillo, J.; Tran, J.; White, N.; Arellano, M.; Fleck, B.; Marinkovic, D.; Tucci, F.; Saunders, J.; Foster, A.; Chen, C. Bioorg. Med. Chem. Lett. 2005, 15, 5237–5240. 5. Jiang, W.; Chen, C.; Marinkovic, D.; Tran, J.; Chen, C. W.; Arellano, M.; White, N.; Tucci, F. "Practical Asymmetric Synthesis of Branched 2-Piperazinylbenzylamines by 1,2-Additions of Organometallic Reagents to N-tert-butanesulfinyl Imines," J. Org. Chem. 2005, 70, 8924–8931. 4. Tucci, F.; White, N.; Markison, S.; Joppa, M.; Tran, J.; Fleck, B.; Madan, A.; Dyck, B.; Parker, J.; Pontillo, J.; Arellano, M.; Marinkovic, D.; Jiang, W.; Chen, C.; Goga, K.; Goodfellow, V.; Saunders, J.; Foster, A.; Chen, C. Bioorg. Med. Chem. Lett. 2005, 15, 4389–4395. 3. Pontillo, J.; Tran, J.; Arellano, M.; Fleck, B.; Huntley, R.; Marinkovic, D.; Lanier, M.; Nelson, J.; Parker, J.; Saunders, J.; Tucci, F.; Jiang, W.; Chen, C. W.; White, N.; Foster, A.; Chen, C. Bioorg. Med. Chem. Lett. 2004, 14, 4417–4423. 2. Chen, C.; Tucci, F.; Tran, J.; Chen, C. W.; White, N. U.S. Patent WO 2004058735, July, 06, 2004. 1. Pontillo, J.; Marinkovic, D.; Lanier, M.; Tran, J.; Arellano, M.; Parker, J. Nelson, J.; Chen, C.; Chen, C. W.; Jiang, W.; White, N.; Tucci, F. U.S. Patent WO 2003094918, November, 20, 2003. Show less



Pfizer

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Internship

  • Jun 2000 - Sep 2001