Michael Tesch Email & Phone Number

Global, Global, Oo

Global, Global, Oo

St. Louis, Mo, Us

Develop, scale, and transfer protein purification and antibody drug conjugate (ADC) processes using natural, recombinant, and synthetic sources to cGMP Manufacturing. Protein conjugation work has centered on the use of SafeBridge category 3 and 4 highly potent compounds (HPC).

• Scientific liaison between off-site R&D group and site Manufacturing for the transfer of the protein capture and purification of a Phase I/II monoclonal antibody based biopharmaceutical to site for Phase III scale-up. As a member of the transfer team, I worked successfully to meet or exceed all of the accelerated timeline goals. Associated tasks include: - Collaborate with transfer team and off-site development to identify gaps in the design for manufacturing and mitigate associated risks. - Review master batch records, master formulation records, Unicorn methods, SOPs, and tech transfer documents used in manufacturing. - Communicate with suppliers and other external sources to ensure that materials of construction are compatible with process stream and meet cGMP requirements.• Write and execute cGMP-compliant documentation, including experimental and process validation protocols and final reports. • Provide technical documentation, including data and rationale required for resolution of non-conformances.

St. Louis, Mo, Us

• Transferred and developed high-purity protein products to cGMP manufacturing in a customer-centric environment. • Reported on project status to internal and external customers through written and verbal reports. • Worked with a team to develop and validate analytical and surface sampling methods required for cleaning validation.• Process development and production of high-purity protein products ranging from milligram to kilogram scale.• Acted as lead chemist or shift leader for large-scale production runs.• Mentored new chemists.

Master Of Science (Ms), Entomology

Bachelor Of Science (Bs), Biochemistry