Dante Pillon, Iii Email & Phone Number

Milford, Nj, Us

Boston, Ma, Us

Boston, Ma, Us

Lawrence Township, Nj, Us

Responsible for supporting commercial drug product definition, leading process development, scale-up, registration stability batch mfg., technology transfer, supporting validation, and providing in-line technical support. Key experience includes support of registration stability planning and manufacture for multiple programs, PAI readiness, process validation planning and support, scale up and tech transfer studies, data trending and analysis, and regulatory filing support. Heritage Celgene

Summit, New Jersey, Us

Summit, New Jersey, Us

Engineer I, Drug Product Process Development.Member of a dynamic scientifically driven team, dedicated to the development and optimization of robust manufacturing processes for drug products.Execute process development strategies to define manufacturing processes for commercialization.Design and execute complex experiments to characterize drug product manufacturing processes utilizing various technologies.Apply fundamental engineering principles to characterize and solve process challenges across multiple unit operations, utilizing both experimental and process simulation/modeling approaches.Utilize appropriate research tools, instrumentation, technologies, and methodologies to support efficient and effective drug product process development.Support drug product process development/technology transfer to Contract Research/ Manufacturing Organizations.Contribute to the preparation of CMC regulatory documents.Assume departmental responsibilities for assigned projects and equipment.Maintain safety, regulatory, and compliance standards as they relate to the development of pharmaceuticals.Prepare technical reports, publications and oral presentations.

Summit, New Jersey, Us

Performed analysis on Active Pharmaceutical Ingredients, dosage forms, raw materials and components, in a cGMP environmentReviewed, evaluated and documented test results and in technical reportsRecommended improvements in existing departmental analytical technology.Supported and co-ordinate stability studiesIndependently Develop and validate analytical methodsPrepare technical development and validation reportsPerform laboratory investigations and prepare associated CAPA reportsCoordinate and assist with technical transfersPrimary Technologies: HPLC/UPLC, GC direct and headspace injection, Dissolution, Fiber-optic dissolution, disintegration, Karl Fisher water, LC-MS, Job rotation into Drug Product Development; Process Engineering group July 2015- ongoing, o Coordinate batch manufacture for development purposeso Participate in strategic planning and discussions for Intended Commercial Formulation decisionso Conduct Risk Assessment matrices for various systems and processeso Design and study batch processing at scale-up o Determine critical processing parameterso Provide statistical analysis of process output to understand and optimize parameterso Work with clinical, transnational, drug substance development, project management, and other colleagues to drive project into later clinical stages.

Legacy Schering-PloughOral and Special Product Development Performed routine Assays on drug substances, dosage forms, raw materials and components, Reviewed, evaluated and documented test results in peer reviewed technical reportsRecommended improvements in existing departmental analytical technology.Independently developed methods for dissolution, HPLC methods for assay, related compounds and content uniformity, Karl Fischer methods for moisture content, and GC methods for measurement of residual solvents.Drafted new test procedures and prepared validation protocols.Well-versed in ICH method validation requirements and cGMP record-keeping.Managed development stability programsCoordinated sample testing at contract research organizations,Performed laboratory investigation studies.Primary Technologies used: HPLC/UPLC, GC (Direct injection and Headspace), Dissolution, LC-MS, KF moisture

Raritan, Nj, Us

Test Method Development and Validation DepartmentAssisted in Development and validation of HPLC methods.Performed stability testing and routine assays. Calibrated Instruments. Provided input on method development.

Doylestown, Pa, Us

Maintained equipment and supplies in Organic, Bio, and General chemistry teaching laboratories. Prepared and tested new student experiments.

Master’S Degree, Chemical Engineering

Bachelor'S Degree, Chemistry