Experience

Syndax Pharmaceuticals

• United States
• Biotechnology Research
• 1 - 100 Employee

• Senior Director, CMC, Small Molecule Drug Substance

  • Feb 2023 - Present

  Waltham, Massachusetts, United States

• Director, Small Molecule Drug Substance

  • May 2021 - Feb 2023

  Waltham, Massachusetts, United States Leading PR&D and manufacturing efforts through CDMOs for Registration and Validation batches of Revumenib (SNDX-5613). Route scouting, selection, optimization, and initial non-GMP/GMP deliveries for pipeline programs. Guided salt, co-crystal and crystalline form screening and selections of pre-clinical candidates. Prepared relevant sections of regulatory documents (IND, RSM Briefing Book, NDA). Troubleshoot issues in the process development work and production.



Johnson Matthey

• United Kingdom
• Chemical Manufacturing
• 700 & Above Employee

• Section Head

  • May 2018 - May 2021

  Managed day-to-day activities of the department (scientific and non-scientific). Reviewed RFPs from customers, wrote proposals with detailed scope of work, budget, and timelines. Led PR&D efforts on 5 late-phase and commercial products. Reviewed equipment accuracy and process knowledge to establish parameter ranges to study (NOR and PAR). Determined Critical Process Parameters (CPPs) through OFAT and statistical DoE studies. Managed development and… Show more Managed day-to-day activities of the department (scientific and non-scientific). Reviewed RFPs from customers, wrote proposals with detailed scope of work, budget, and timelines. Led PR&D efforts on 5 late-phase and commercial products. Reviewed equipment accuracy and process knowledge to establish parameter ranges to study (NOR and PAR). Determined Critical Process Parameters (CPPs) through OFAT and statistical DoE studies. Managed development and manufacturing timelines (Engineering, Registration and Validation campaigns), worked closely with supply chain/sourcing department to better understand RSM availabilities, vendor qualification activities. Identified impurities and implemented impurity control strategies. Show less



Curia

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Group Leader/Senior Research Scientist II

  • Apr 2016 - Apr 2018

  Albany, NY 10 years of experience at AMRI, mostly on early phase development (DRF, Tox, Phase 1). Spent the first 5 years as an individual contributor working at bench on several different projects. Next 5 years in a hybrid environment managing projects from the group (5-6 group members) while working at the bench on an individual project. Most projects were first generation process development: Developed from Medicinal Chemistry routes. Involved major changes in the route, avoiding… Show more 10 years of experience at AMRI, mostly on early phase development (DRF, Tox, Phase 1). Spent the first 5 years as an individual contributor working at bench on several different projects. Next 5 years in a hybrid environment managing projects from the group (5-6 group members) while working at the bench on an individual project. Most projects were first generation process development: Developed from Medicinal Chemistry routes. Involved major changes in the route, avoiding hazardous reagents, telescoping of two or more steps and eliminating column chromatographic purifications. One project was late phase polymer project (Process Validation activities). Hands-on work on wide ranging classes of compounds: Small molecule APIs to polymers (GPC, Tangential Flow Filtration).

• Senior Research Scientist I

  • Mar 2012 - Mar 2016

  Albany, NY

• Senior Research Scientist

  • Jan 2008 - Mar 2012

  Albany, NY



Dr. Reddy's Laboratories

• India
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Research Associate

  • 1997 - 2004