Thomas Fleming

- Responsible for late-stage research & development projects

- Organizes schedules and productions quotas to fulfill demand for clinical doses

- Build out documentation to support multiple new drug products reaching IND status

- Member of hiring and training team to select and onboard new additions to the company

- Spearheading design and implementation of a new lab space to optimize production

- Collaborates with early-stage research teams to expedite development projects

• Member of Pilot Scale Operations Formulations Team
• Collaborated with process development teams to optimize method formulation and execution
• Operated and troubleshooted custom equipment used to manufacture preclinical batches
• Worked alongside technical and analytical teams to characterize product attributes
• Member of Individualized Neoantigen Therapy Team
• Produce personalized therapy products for stage 3 clinical trials
• Utilize standard operating procedures and technology transfer documents to ensure reliability of product quality
• Collaborated on building out and qualifying new laboratory equipment to optimize production efficiency

• Company Overview: GMP, GTP, GDP, GLP lab environment
• Member of Interfyl and Biovance production teams
• Harvest/Dissection Team Lead
• Manufactured FDA approved products in both ISO 5 and 7 cleanroom environments
• Held key role in collaborating on production schedules and reporting regular assessments to management and department administration
• Participated in process development, training, and technical process transfers for existing and future products