Director Of Operations

• Jun 2021 - Present

Associate Director Supply Chain

• Dec 2018 - Jun 2021

Sr. Manager Pharmaceutical Operations

• Feb 2018 - Dec 2018

• Manage external manufacturing partners to define, optimize, and scale GMP manufacturing processes for sterile drug products • Review/approve CMO master batch records, executed batch records for drug substance, drug product and clinical packaging/labeling • Manage clinical supply chain and distribution activities • Author/review technical reports, SOP’s, validation protocols, and regulatory sections of cGMP related documents • Manage external manufacturing partners to define, optimize, and scale GMP manufacturing processes for sterile drug products • Review/approve CMO master batch records, executed batch records for drug substance, drug product and clinical packaging/labeling • Manage clinical supply chain and distribution activities • Author/review technical reports, SOP’s, validation protocols, and regulatory sections of cGMP related documents

Project Manager

• Apr 2017 - Feb 2018

Senior Asscociate Scientist

• May 2014 - Apr 2017

Currently working in our Chemistry, Manufacturing and Controls (CMC) group where I focus on pharmaceutical development. As a member of the DNS CMC team I have gained a working knowledge of cGMP, ICH and FDA CMC guidelines. Experiences include: • Initiate and manage clinical trial material (CTM) manufacturing at our CMOs o Emphasis on maintaining Quality, Cost and Timelines o Site visits during GMP manufacturing o Reviewed Deviations, OOTs, OOSs, and CAPA… Show more Currently working in our Chemistry, Manufacturing and Controls (CMC) group where I focus on pharmaceutical development. As a member of the DNS CMC team I have gained a working knowledge of cGMP, ICH and FDA CMC guidelines. Experiences include: • Initiate and manage clinical trial material (CTM) manufacturing at our CMOs o Emphasis on maintaining Quality, Cost and Timelines o Site visits during GMP manufacturing o Reviewed Deviations, OOTs, OOSs, and CAPA documentation • Management of packaging, labeling, and distribution of CTMs for phase I and phase II clinical studies • Participated in quality audits of potential CMO partners • Prepared, reviewed, and executed cGMP batch records • Created and reviewed Product Development Reports (PDRs) • Reviewed stability data, specifications, C of A’s, and module 3 of DNS IND filings • Design and evaluation of powder blends for solid oral dosage forms • Actively review blend uniformity, content uniformity, dissolution, assay and impurity data • Familiar with HPLC/UPLC method development and validation • Designed an oral solution for a phase I clinical study • Participated in Site Initiation Visits (SIVs) at clinic sites • Created a Pharmacy Manual and Batch Record for pharmacy staff to support compounding of the oral solution o Preformed onsite training to Clinical Pharmacist and staff on how to prepare the oral solution • Managed activities, coordinate sample shipments for analysis and managed inventory of consumables at our phase I clinic sites • Actively interact with our Clinical Operations, Regulatory Affairs and Quality groups • Manage the maintenance of our NMR lab as well as run 2D and VT experiments for colleagues

Associate Scientist III

• Nov 2010 - May 2014

Medicinal Chemist developing small molecules for CNS targets that center around memory and cognition.

Associate Scientist

• Sep 2008 - Nov 2010

Current Group: Neuroscience

Research Associate

• Sep 2005 - Sep 2008

Group: Pain and Related Disorders