Consultant

  (610) 462-4090

  info@qualitysolutionsnow.com

Product development leader with experience in small molecule, biologics, and oligonucleotide product development and manufacturing from preclinical to commercial launch. Expert in root cause failure analysis, quality risk assessment, nitrosamine risk assessment, scale-up/tech transfer challenges, and vendor qualification. Skilled in writing the CMC section for IND, IMPD, NDA, BLA filing, and responding to health authority questions.

CORE COMPETENCIES

  • Process Development/Process Optimization
  • Solid-state Chemistry/Pre-formulation
  • Pediatric/Neo-natal formulation
  • Internal/External Tech-Transfer
  • CDMO/CRO Management
  • Raw Materials/Component commercial qualification
  • Expiry extension/Quality risk assessment
  • Nitrosamine Risk Assessment (Small molecule/biologics)
  • Combination Product Development
  • Technical Writing/Protocols/Reports/SOP/WI
  • Change Control/CAPA/Deviation Management
  • Stability/QC Testing/Method Development
  • Statistical Data Analysis/Trend reports/Metrics
  • IP filling support/In and out Licensing

SELECTED ACCOMPLISHMENTS

  • Supported Nitrosamine risk assessment for commercial and clinical assets for all biologics programs at Bristol Myers Squibb (BMS).
  • Worked on Covid-task force to support the components/consumable shortage by expiry extension and quality risk assessment at BMS.
  • Commercial qualification of raw materials/filters/single use components from alternate supplier to mitigate supply chain shortage at BMS.
  • Provided formulation and stability support for mRNA Covid vaccine at room temperature for Translate Bio and optimized Lyophilization cycle/spray drying conditions for mRNA/SiRNA drug product for inhalation.
  •  Summarized all drug product data to write the pharmaceutical development report and NDA for Bylvay (Odevixibat) at Albireo Pharma.
  • Completed global harmonization of Shire products across all sites for visual appearance testing internally and with USP <790> and <1790> requirements.

PROFESSIONAL EXPERIENCE

  • Black Diamond Therapeutics – Director/Senior Director Drug Product Development, 05/22-10/24
  • Bristol Myers Squibb – Senior Manager/Principal Scientist, Devens, 03/21-05/22
  • Translate Bio (Sanofi) – Formulation and Product Development Consultant, 04/20-03/21
  • Albireo Pharma (Ipsen) – Formulation and Product Development Consultant, 04/20-03/21
  • Agios Pharmaceuticals – Principal Scientist Formulation, 05/19-04/20
  • Shire – Lead Particle Analysis Lab, Technical Operations, 08/18-12-18
  • Vertex Pharmaceuticals – Research Scientist, 08/16-07/18
  • Henkel Corporation – Surface Scientist, 09/14-12/15

EDUCATION

  • PhD, Chemistry (Materials), Carnegie Mellon University, Pittsburgh, PA, 08/11-07/13
  • Graduate studies in Chemistry (Nanomaterials), University of Toledo, Ohio, 08/08-08/11
  • Masters in science, Physical Chemistry, University of Delhi, India, 08/04-07/07
  • Bachelors in Science, Chemistry, University of Delhi, India, 08/00-06/04

CERTIFICATION

  • Process Validation for Drugs and Biologics, The Center for Professional Innovation & Education, Inc., 03/23
  • Pharmaceuticals Solids: Essential Knowledge and Advance Concepts, Albany Molecular Research Inc., 09/16

AFFILIATIONS

  • American Chemical Society (ACS), 2008
  • Royal Society of Chemistry (RSC), 2010
  • Materials Research Society (MRS), 2016
  • International Precious Metal Institute (IPMI), 2012
  • American Association of Pharmaceutical Scientist (AAPS), 2019

PUBLICATIONS AND PRESENTATIONS

  • https://scholar.google.com/citations?user=X4wymJIAAAAJ&hl=en
  • 19 publications (complete list of publications and presentations available on request)