Experience

Xilio Therapeutics, Inc.

• United States
• Biotechnology Research
• 1 - 100 Employee

• Senior Director, CMC

  • Apr 2022 - Present

  Lead a group of highly experienced directors and manage 3 pipeline products development including cell bank, cell culture, purification, analytical, QC, formulation, fill/finish, pack & labeling. Provide CMC leadership and technical oversight of external GMP manufacturing, e.g., batch records, specifications, deviations, change controls, release/stability/characterization testing. Compile and review CMC sections for Regulatory filing (e.g. IND and IMPD) Lead a group of highly experienced directors and manage 3 pipeline products development including cell bank, cell culture, purification, analytical, QC, formulation, fill/finish, pack & labeling. Provide CMC leadership and technical oversight of external GMP manufacturing, e.g., batch records, specifications, deviations, change controls, release/stability/characterization testing. Compile and review CMC sections for Regulatory filing (e.g. IND and IMPD)



OncXerna Therapeutics

• United States
• Biotechnology Research
• 1 - 100 Employee

• Director, CMC and Clinic Research

  • Jul 2018 - Apr 2022

  Oversaw the CMC responsibility for all drug substance, drug products, and supply chain activities; management of Contract Manufacturing Organizations including budget, timeline, quality, scope of all CMC deliverables; supporting supply chain activities; writing and reviewing documents for INDs, IMPD, and other regulatory section submissions and correspondences Oversaw the CMC responsibility for all drug substance, drug products, and supply chain activities; management of Contract Manufacturing Organizations including budget, timeline, quality, scope of all CMC deliverables; supporting supply chain activities; writing and reviewing documents for INDs, IMPD, and other regulatory section submissions and correspondences



Alexion Pharmaceuticals, Inc.

• United States
• Biotechnology Research
• 700 & Above Employee

• Associate Director, Drug Product Development

  • 2015 - 2017

  Continued to serve as Kanuma® Product lead and fulfilled the Post-marketing commitments (PMCs) with the FDA; developed an optimized liquid formulation; managed vendors/CROs and accomplished multiple post-marketing commitments per the FDA request Continued to serve as Kanuma® Product lead and fulfilled the Post-marketing commitments (PMCs) with the FDA; developed an optimized liquid formulation; managed vendors/CROs and accomplished multiple post-marketing commitments per the FDA request



Synageva BioPharma Corp.

• United States
• Biotechnology Research
• 1 - 100 Employee

• Associate Director, Drug Product Development

  • 2014 - 2015

  Served as Drug Product formulation head and defined Kanuma® formulation strategies for its BLA; identified Baxter BioPharma Solutions as a CRO and developed a lyophilized backup formulation; identified Baxter Oncology GmbH as a CMO and completed manufacturing transfer prior to BLA approval; optimized DP fill/finish process and achieved better Quality control Served as Drug Product formulation head and defined Kanuma® formulation strategies for its BLA; identified Baxter BioPharma Solutions as a CRO and developed a lyophilized backup formulation; identified Baxter Oncology GmbH as a CMO and completed manufacturing transfer prior to BLA approval; optimized DP fill/finish process and achieved better Quality control



Biogen

• United States
• Biotechnology Research
• 700 & Above Employee

• Scientist, Protein Pharmaceutical Development

  • 2007 - 2014

  Maintained responsibilities for formulation and process development for both early and late stage Drug Products; developed a pre-filled syringe presentation for PLEGRIDY™ and supported its BLA filing. Served as SME on high concentration formulation, lyophilization, protein particles characterization and control. Recipient of 2011 Biogen’s Best Scientific Award. Maintained responsibilities for formulation and process development for both early and late stage Drug Products; developed a pre-filled syringe presentation for PLEGRIDY™ and supported its BLA filing. Served as SME on high concentration formulation, lyophilization, protein particles characterization and control. Recipient of 2011 Biogen’s Best Scientific Award.



Pfizer

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Medical Affairs

  • 1998 - 2001

  Served as Medical Affairs lead and responsible for two phase-IV clinical trials in China including the treatment of asthma by high dose methylprednisolone (Solu-Medrol®) as well as treatment of unstable coronary artery disease (UCAD) by low-molecular-weight heparin (Fragmin®). Served as Medical Affairs lead and responsible for two phase-IV clinical trials in China including the treatment of asthma by high dose methylprednisolone (Solu-Medrol®) as well as treatment of unstable coronary artery disease (UCAD) by low-molecular-weight heparin (Fragmin®).