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Carolyn W. Wing
Director Cmc Project Management @WuXi Chemistry
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WORK HISTORY
Director Cmc Project Management @WuXi Chemistry
CMC project management for DS and DP development and manufacturing of small molecules from candidate nomination through NDA to commercialization.
EDUCATION
Northeastern University
M.Sc., Chemistry
University of Wisconsin-Madison
B.Sc., Pharmaceutical Sciences
ABOUT CAROLYN W. WING
CMC professional with 20+ years of fast-paced direction and execution of pharmaceutical development and manufacturing activities. Strong project and cross-functional team leadership and proven ability to deliver successful IND-enabling CMC packages across therapeutic areas. Broad demonstrated technical expertise in analytical development, pre-formulation, and early clinical formulation. Bilingual (English and Mandarin). Some of my key accomplishments include: PROJECT LEADERSHIP Drove multiple successful milestone transitions, including a technically challenging pre-clinical candidate with compelling First-In-Human formulation strategy. Improved productivity within exploratory development phase (savings of 3 months) for an accelerated project. Developed cost conscious formulation strategy, including driving the functional and cross-functional endorsement. Supported out-licensing activities with scientific storyline, data room compilation, and Q&A sessions, including formulating the data disclosure strategy with internal stakeholders. TEAM LEADERSHIP Delivered strategic priorities despite resource constraints via laser-focused priorities and creative deployment of talents. Expanded CMC lab capabilities with acquisition of new technologies/equipment and further increased the group’s impact. Drove lab needs assessment leading to lab design suitable for future pipeline and further innovation. TECHNICAL LEADERSHIP Developed early clinical formulation / drug product, meeting biopharmaceutical, clinical, and regulatory requirements, including technology transfer to CDMO and reviewing of formulation reports and master / executed batch records. Contributed to internal Development Manual, strategic documents (technical development plan and risk register), and IMPD for Phase 1 readiness. Developed enteric capsules and IV infusion formulations to address emesis observed in the pre-clinical tox species. Provided technical directions on solving the poor reproducibility of a developed stability indicating method.
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