Eric Mach Email & Phone Number

Boston, Ma, Us

Boston, Ma, Us

Consultant to a Nasdaq-100 listed multinational biotechnology and pharmaceutical company-Provided guidance and expertise in shipping qualification and cold-chain logistics for all drug development product stages. Suggested appropriate distribution solutions based on industry standards, logistical constraints of the client, and government regulations. Acted as a subject matter expert (SME) for change controls to assess the distribution methodology of new products. Experience with multiple dosage forms, packaging configurations, temperature requirements, and shipping solutions.-Led performance qualification activities with input and cooperation from a cross-functional team. These included internal departments of the client and contract manufacturing organizations (CMOs) based both domestically and internationally. Supported operational qualification activities for new shipping solutions.-Managed multiple studies simultaneously in the clinical and commercial pipeline, with a focus on clinical qualification activities to support FDA filing and patient timelines. Authored test protocols and reports following good documentation practice (GDP) to support these qualifications.

Boston, Massachusetts, Us

- Major contributor in performing analyses and authoring sections for a large-scale process comparability report that was part of an FDA filing. Over the course of months, collected, organized, and analyzed data from all aspects of the process while communicating with team members to ensure all components were relevant and within scope.- Use of JMP and Excel to perform large-scale data analyses of process parameters in order to address problems in AAV product quality. Created and organized hundreds of different correlations and statistics to attempt to bring the project out of a clinical hold. - Updated and organized data from executed manufacturing runs within larger masterfiles in order to keep trends/graphs up to date

Amsterdam, 1105Bp, Nl

- Supported the upstream process development team with R&D lab work aimed at improving current manufacturing procedures. Became proficient in running upstream unit operations within the lab to produce AAV (adeno-associated virus) through the manipulation of insect cell cultures in small and large scale bioreactors.- Performed extensive data analysis of executed lab runs in order to further optimize the process by improving yield and product quality. Utilized Minitab to visualize and quantify relevant statistical parameters which were periodically presented to the greater team.- Managed and ordered lab equipment required for each run; kept in close contact with supply chain in order to preemptively address any potential issues.

Master Of Science - Ms, Engineering/Industrial Management

Bachelor Of Science - Bs, Bioengineering And Biomedical Engineering

Education record