Adam Grobin

About Adam Grobin

Results-driven executive with broad-based experience in active pharmaceutical ingredients (API), pre-formulation, analytical and microbiological methods, formulation development, drug product development, clinical trial supply manufacturing, stability studies, Chemistry manufacturing and controls (CMC) regulatory issues, support for production scale-up, analytical technology transfer, pre-approval readiness, and regulatory submissions / commercial registrations. Track record of leading functional and matrixed teams to develop and deploy successful chemistry, manufacturing, and control strategies to from first in human studies through post-approval change implementation. Staff Leadership & Development of Scientists and Managers Small molecule API / Drug Product DevelopmentAnalytical and Microbiological Development, Method validationEarly phase / late phase clinical supplies manufacturingRegulatory Filings (IND, IMPD, NDA, MAA,J-NDA)Ensuring contract research organization (CRO) and contract manufacturing organization (CMO) facilities possess the necessary technical and compliance competenciesSolid oral dose (tablet, capsule, orally disintegrating, granule, liquid, suspension, modified release, sustained release, enteric coated), parenteral (intervenous - IV, intermuscular - IM, intraocular), topical dermal, topical ocular, drug coated coronary stent, PLGA implant.

Experience

1. Adjunct Faculty - Instructor of Chemistry

   San Diego Community College District

   Jan 2020 — Present · San Diego, US

   Instruct, encourage, motivate community college students learning chemistry at an introductory level through Organic Chemistry I/II,

Education

• Boston College

  B.S.

• Duke University

  Ph.D.

Skills

• Hplc
• Regulatory Affairs
• Validation
• Clinical Trials
• Analytical Chemistry
• Technology Scouting
• Impd
• Technology Transfer
• Protein Chemistry
• Cmc
• Api
• Analytical Method Validation
• Apis
• CMO Management
• Regulatory Requirements
• Ind
• Pharmaceutical Industry
• Sop
• Fda
• Chemistry
• 21 Cfr Part 11
• Assay Development
• Regulatory Submissions
• Ctd
• Dossier Preparation
• Gmp
• CRO
• Drug Development
• Oncology
• Biopharmaceuticals