A dynamic and results-driven pharmaceutical sciences 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. Possesses a proven track record of leading functional and matrixed teams to develop and deploy successful chemistry, manufacturing, and control strategies to enter into IND and IMPD submission, and ultimately secure marketing authorization. Specialties: Department & Project Management Staff Leadership & Development of Scientists and Managers Small molecule API / Drug Product Development Analytical and Microbiological Development, Method validation Early phase / late phase clinical supplies manufacturing Regulatory Filings (IND, IMPD, NDA, MAA,J-NDA) Ensuring contract research organization (CRO) and contract manufacturing organization (CMO) facilities possess the necessary technical and compliance competencies Solid 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.

Sr. Director @ Analytical Sciences and Applied Microbiology / Pharmaceutical Analysis and Microbiology departments of Allergan Global Pharmaceutical Sciences. Lead Analytical Sciences and Applied Microbiology functions to develop /apply phase appropriate methods and technologies in the advancement of new products, formulations, packaging. Directed Pharmaceutical Analysis and Microbiology department of global pharmaceutical sciences to provide timely analytical chemistry and microbiology method validation and cGMP data generation in support of clinical trials and product registrations. From March 2013 to November 2014 (1 year 9 months) Orange County, California AreaIndependent Pharmaceutical Consultant @ Strategic chemistry manufacturing, and controls (CMC) consulting. Pharmaceutical development subject matter expert. From December 2012 to March 2013 (4 months) Consulting Analytical Scientist and Senior Director Analytical @ A start-up stage company developing drug eluting stents with innovative surface modification technology using supercritical fluids. Established, developed and implemented analytical methods and systems that went on through Notified Body inspection resulting in zero non-conformities. From August 2011 to June 2012 (11 months) Executive Director - Pharmaceutical and Analytical R&D @ From 2010 to 2011 (1 year) Senior Director - Analytical Development @ Adam expanded the analytical development and microbiology organization to support a two-fold increase in drug product projects (13), ranging from pre-FIH (toxicology) to Phase III. Transitioned from a function-based line management structure to a matrixed global CMC team-driven organization. Provided scientific and technical leadership for global product development / regulatory approval efforts for Eisai NCEs eribulin mesylate (Halaven), and eritoran tetrasodium (Torceptor). Key contributor to value enhancement through drug delivery for market products Zonegran and AcipHex. From 2004 to 2010 (6 years) Director - Analytical Development @ Adam lead and trained 8 analytical chemists developing methods, specifications, and expiry dating for IV drug product in clinical development. Developed systems for routine release of raw materials, packaging, real-time assay for in-process material, clinical trial supply QC, stability, and equipment cleanliness verification for clinical trial manufacturing. From 2000 to 2004 (4 years) Senior Research Scientist @ From 1997 to 2000 (3 years) Senior Research Investigator @ From 1997 to 1997 (less than a year) Sr. Research Scientist @ From 1993 to 1997 (4 years) Research Scientist @ From 1990 to 1993 (3 years)

Ph.D., Analytical Chemistry @ Duke University From 1985 to 1990 B.S., Chemistry @ Boston College From 1983 to 1985 Adam Grobin is skilled in: Technology Transfer, GMP, Drug Development, Pharmaceutical Industry, Analytical Chemistry, Validation, Regulatory Submissions, HPLC, Chemistry, FDA, Clinical Trials, Assay Development, CRO, Regulatory Requirements, Regulatory Affairs