Thomas Scarpa Email & Phone Number

Lawrence Township, Nj, Us

Lawrence Township, Nj, Us

Lawrence Township, Nj, Us

November 2019: Bristol-Myers Squibb merged with Celgene.

Summit, New Jersey, Us

Quality oversight of CMC and laboratory operations (in-house and at CSPs) which include: - Analytical, formulations development, metrology and validation services for GMP activities conducted during drug development. Including API and drug product release for clinical supplies. - Manage a staff responsible for data review for method development, method transfer, registrational stability, SOP's, analytical protocols, validation reports, specifications, deviations, investigations, CAPA's, Quality Agreements, etc. - Develop policies and practices based on regulations, industry guidance's and Celgene requirements. - Act as the FDA liaison during inspections and assist regulatory affairs in IND, NDA/ANDA or BLA submissions.

Princeton, Nj, Us

Direct the GMP SM (starting material) and API manufacturing campaigns to support clinical and commercial supplies. - Responsible for API manufacturing process validation commitments.- Manage the API demand for ongoing/new clinical studies and commercial supply forecast.- Support CMC compilation and updates for regulatory documents which include IND annual reports, IND amendments, IMPD, NDA, as well as any quality PAI preparedness for facilities or possible agency audits related to API manufacturing & release.- Fiduciary responsibilities for API forecast models and financial budgets of those models.- Support Analytical R&D and stability programs, and work closely with quality assurance and regulatory affairs personnel both internally and at our manufacturing/testing partners.

Compiled portions of the Chemistry, Manufacturing and Controls (CMC) sections of the NDA for Omthera's lead drug candidate EPANOVA® which include analytical, stability and pharmaceutical development for drug substance and drug product. Supported stability summary conclusions, specification justifications/proposals and post-approval commitments. Began integration to oversee API manufacturing campaigns in preparation of commercial readiness. These included API batch records review, oversight of manufacturing operations, preparation of engineering (pre-validation) and process validation campaigns.

Director of pharmaceutical development, leading analytical R&D, stability/reassay programs, specification development and inventory control of reference materials. Support clinical and commercial supply planning, CMC dossier development, technical lead for contract laboratory evaluation and quality assurance audits. Drug candidates portfolio development phases include pre-clinical through phase IV.

Lawrence Township, Nj, Us

Managed the Analytical activities of Phase II through Phase IV drug development (including stability programs) for more than fifteen BMS compounds of varying therapeutic areas. Supported chemistry, manufacturing, pharmaceutics, drug safety and regulatory functions to provide data and documentation on drug substance and drug products for over 10 registrational filings of new chemical entities and product extensions. Managed two (2) analytical outsourcing project managers overseeing contract research organization workflow in support of IND, NDA, MAA, and JNDA filings. Authored analytical R&D departmental SOPs, developed company guidelines (related to how to select, evaluate and outsource analytical projects, methods, transfers and long term stability studies) from the clients perspective.