Joyce Lin Email & Phone Number

Spearheaded the regulatory CMC strategy for second-generation allogeneic CAR T therapy programs, overseeing regulatory submission timelines and all critical deliverables and activities. Tracked regulatory risks and commitments and guided cross-functional strategic discussions for risk mitigation. Ensured compliance with global regulatory requirements while.

Co-led (with alliance partner) the regulatory CMC strategy for an autologous, ex vivo edited hematopoietic stem cell therapy for the treatment of sickle cell disease and transfusion-dependent thalassemia during its pivotal development. Harmonized CMC dossier and managed global regulatory submissions. Ensured compliance with regulatory requirements across.

Waltham, MA

Ensured accuracy of internal documentation and compliance with regulatory requirements across multiple countries throughout product development. Represented regulatory and provided guidance to CMC team during development of CMC strategies.

Supported regulatory CMC development of early-phase ADC programs. Ensured compliance with regulatory requirements across multiple countries throughout product development. Responsible for lifecycle management of ongoing clinical trials and ensured timeliness of CMC amendments to INDs and CTAs.

Develop and qualify analytical methods. Transfer methods to quality groups and training them. Formulation of monoclonal antibodies and ADCs.Analyze release, stability, and in-process samples using established analytical methods. CGE, CZE, imaged cIEF, HPLC, SDS-PAGE, spectroscopy, analytical chemistry.Strategic planning and project management support in.

Waltham, MA

Develop and qualify analytical methods. Transfer methods to quality groups and training them. Formulation of monoclonal antibodies and ADCs.Analyze release, stability, and in-process samples using established analytical methods. CGE, CZE, imaged cIEF, HPLC, SDS-PAGE, spectroscopy, analytical chemistry.

Analyzed in-process, release, and stability conjugate samples using established analytical methods. Optimized existing analytical methods to improve performance of assays.Develop and qualify analytical methods. Transfer methods to quality group/CRO and training them. CGE, CZE, imaged cIEF, HPLC, SDS-PAGE, analytical chemistry.

Analyzed in-process, release, and stability conjugate samples using established analytical methods. Optimized existing analytical methods to improve performance of assays.HPLC, SDS-PAGE, spectroscopy

M.Eng., Biomedical Engineering

B.Sc., Chemical Engineering & Mathematics (Minor In Chemistry)

Activities and Societies: HKSBS, HKSS, SSS, Tau Beta Pi