Experience

ACELYRIN, INC.

• United States
• Biotechnology Research
• 1 - 100 Employee

• Director

  • Oct 2022 - Present

  • Accountable for DS process lifecycle management, technology transfers, process development and implementation, as well as related timelines • Leadership of all activities related to Drug Substance and the DS aspects on the cross-functional Technical Operations Team • Oversight and guidance of DS process development, improvements, characterization, and validation in collaboration with internal and external peers, partners, contractors, and consultants • Management of CDMO and process development contractors to formulate plans and advance DS aspects of the projects • Troubleshooting and resolution of DS tech. transfer and manufacturing problems • Help frame and contribute to DS aspects of program and process risk assessments • Support of OOS, OOT, and Quality deviation investigations as well as change control activities • Collaborate with Regulatory Affairs colleagues to draft DS elements of clinical and commercial regulatory submissions; support responses to health authority questions or interactions requiring DS process knowledge • Leadership of DS process raw material troubleshooting and strategy development • Support of DS aspects of supplier selections • Support of day-to-day CMO-related activities including GMP production • Drafting of DS manufacturing history and development reports • Review of all DS-related GMP and non-GMP supporting documents related to DS development and manufacturing including protocols, master batch records, executed batch documentation, reports, etc. • Partnering with other members of the Technical Operations Team to develop the product control strategy throughout product development and commercialization Show less



Nektar Therapeutics

• Biotechnology
• 300 - 400 Employee

• • Jul 2021 - Oct 2022

  ● Leadership and supervision of a high functioning technical team responsible for development, characterization, validation, data management and manufacturing support of late-stage biologics from fermentation through purification to bulk drug substance● Authoring and review of regulatory filings (BLA, INDA, and IND sections) and health authority responses● Represented functional group and led CMC teams to develop strategies and plan for development and commercialization of Biologics● Technical leadership and management of CMOs and CROs for manufacturing and process validation activities for upstream and downstream processes Show less

• • Jan 2020 - Jul 2021

  ● Leading teams for process development, process optimization and process characterization of protein refolding, protein purification and protein conjugation● Tech transfer, oversight of process development, characterization, validation, scale-up and GMP manufacturing activities at CMOs● Reviewed and authored batch records, technical protocols and reports and CMC sections of regulatory filing documents

• • Aug 2018 - Jan 2020

  ● Serving as the CMC Lead for a biologics program leading a multi-functional team● Leading teams for process development, process optimization and process characterization of protein refolding, protein purification and protein conjugation● Tech transfer, oversight of process development, scale-up and GMP manufacturing activities at CMOs● Reviewed and authored batch records, technical protocols and reports and CMC sections of regulatory filing documents



Bristol Myers Squibb

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• • Jul 2017 - Aug 2018

  ● Process development, process characterization, technology transfer, and manufacturing support for multiple mid to late stage protein therapeutics● Primary functional area representative on cross-functional CMC lead teams for high impact drugs● Developed and characterized depth filtration, TFF (including high concentration), and cryogenics steps for multiple protein therapeutics ● Provided clinical manufacturing support at multiple sites providing expertise on large scale chromatography and filtration operations● Authored and reviewed in-process control documents, development reports, protocols, regulatory filings like INDs and BLAs, etc.● Leadership and supervision of direct reports Show less

• • Dec 2014 - Jul 2017

  ● Process development, process characterization, technology transfer, and manufacturing support for multiple mid to late stage protein therapeutics● Primary functional area representative on cross-functional CMC lead teams for high impact drugs● Developed and characterized depth filtration, TFF (including high concentration), and cryogenics steps for multiple protein therapeutics



The University of Texas at Austin

• United States
• Higher Education
• 700 & Above Employee

• Graduate Research Assistant

  • Sep 2009 - Dec 2014

  ● Designed novel protein formulations utilizing combinations of excipients to lower the viscosity of protein formulations by nearly an order of magnitude compared with solutions ● Introduced tangential flow filtration processing for production of high concentration protein formulations to enable easy scale-up to industrial processing ● Led a team of graduate and undergraduate students across multiple research groups to gather high quality data ● Designed novel protein formulations utilizing combinations of excipients to lower the viscosity of protein formulations by nearly an order of magnitude compared with solutions ● Introduced tangential flow filtration processing for production of high concentration protein formulations to enable easy scale-up to industrial processing ● Led a team of graduate and undergraduate students across multiple research groups to gather high quality data



Homi Bhabha Centre for Science Education (HBCSE), TIFR

• India
• Education
• 100 - 200 Employee

• Undergraduate Student Researcher

  • Apr 2006 - Jun 2009

  Conducted research investigating the dimerization and phase behavior of sodium oleate surfactant solutions using surface tension measurements as an undergraduate researcher during summer breaks. Conducted research investigating the dimerization and phase behavior of sodium oleate surfactant solutions using surface tension measurements as an undergraduate researcher during summer breaks.