Alycia Fulton

Senior Scientist, Downstream Msat @TG Therapeutics, Inc.

Represented organization as personnel-in-plant (PIP) during commercial manufacturing campaign\\\\n*Contributed to two approved regulatory applications (BLA and MAA), including authoring prompt responses to agency questions and updating CMC module sections as needed\\\\n*Advocated for process improvements to key stakeholders by defending rationale and demonstrating robust ROI, which has enabled cost savings and improved process yield\\\\n*Analyzed manufacturing data to identify potential process improvements and evaluate external literature to support (or challenge) hypotheses\\\\n*Oversaw development and GMP production of next generation drug substance formulation with successful production of 4 clinical batches in 4 months\\\\n \\\\n\\\\n \\\\n \\\\n\\\\n \\\\n