Linda Hoo is a seasoned Senior Scientist II at Gilead Sciences, operating at the Associate Director level within the Formulation and Process Development team. With over 13 years of robust experience in drug product (DP) fill/finish processes and both parenteral solid and liquid formulation development,...
Linda Hoo is a seasoned Senior Scientist II at Gilead Sciences, operating at the Associate Director level within the Formulation and Process Development team. With over 13 years of robust experience in drug product (DP) fill/finish processes and both parenteral solid and liquid formulation development, Linda has established herself as a key player in the mid-to-late stage clinical product development of peptide formulations. Her current role involves supporting the tech transfer of peptide parenteral drug products for clinical batch GMP manufacturing, ensuring that all processes are compliant with regulatory standards while maintaining the highest quality.
Linda leads a bioanalytical lab focused on the biophysical characterization of peptides and parenteral formulations during clinical development phases 1 through 3. Her expertise in sterile manufacturing of parenteral injectables, including both lyophilized and liquid products, positions her as a subject matter expert in the field. She excels in collaborative problem-solving, project planning, and strategy development, which are critical for navigating the complexities of formulation and process development.
As she looks to the future, Linda is eager to leverage her extensive background in process development or engineering, potentially stepping into a leadership role in MSAT (Manufacturing Science and Technology) or CMC (Chemistry, Manufacturing, and Controls). Her skills in assay development, regulatory affairs, and process validation, combined with her leadership capabilities, make her well-equipped to drive innovation and efficiency in the biopharmaceutical industry. Linda's commitment to advancing drug development processes underscores her passion for improving patient outcomes through effective formulation strategies.
