senior director biologics analytical development cmc lead at exelixis@ Exelixis
Castro Valley, California, United States
Weijun L.
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FlashIntel GPTWeijun L. is a highly experienced professional with 22.2 years of work experience in protein chemistry, GMP, HPLC, and analytical chemistry. Currently, he is focused on antibody-drug conjugates and bispecific antibodies. He has leadership experience in biological product development, manufacturing, and control, and has supported 15 biological products from preclinical development to product license applications. Weijun L. has extensive knowledge of protein characterization, quality system elements, and quality systems. He has worked in various roles, including Senior Director, Biologics Analytical Development/CMC Lead at Exelixis and Director of Analytical Development and Quality Control at Allakos Inc.
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About
- Therapeutic areas span from hematology, woman's diseases, autoimmune diseases to oncology. Currently focus on antibody-drug conjugates and bispecific antibodies. - Leadership experience in biological product development, aka chemistry, manufacturing and control (CMC) and commercial operation. - Supported >15 biological products from preclinical, clinical development to product license application/launch including Kovaltry® and JIVI® (FDA approved in 2016 & 2018, respectively). Authored and reviewed CMC CTD for IND/IMPD/BLA/MAA. - Postapproval change and product lifecycle management. Deficiency letters. IMEM country registration. Commercial product APR/PQR. - GMP compliance and inspection leadership experience. - Technical expertise in release/stability assay development, testing, validation, transfer, change, comparability and trouble-shooting. Extensive experience with protein characterization. Solid experience with quality system elements including change control, deviation management, CAPA, OOS, etc. - Experience in recombinant proteins, monoclonal antibodies, protein PEGylation and antibody-drug conjugate. - Experience in liposome formulation, PEGylated lipid nanoparticles, a formulation technology critical for RNA or DNA therapy (e.g. Covid-19 mRNA vaccine).
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senior director biologics analytical development cmc lead at exelixis
Biotechnology Research
Weijun L.'s Professional Milestones
- Associate Specialist And Postdoctoral Fellow (2001-09-01~2006-03-01): Contributing to successful research projects and engaging in research.
- Senior Research Scientist, Liposome Project (2006-01-01~2007-01-01): Successfully conducted biomedical experiments, contributing to advancements in oil extraction and pharmaceutical research.
Skill
Protein Chemistry
Gmp
Hplc
Analytical Chemistry
Validation
Monoclonal Antibodies
Chemistry
Formulation
Dna
Drug Delivery
Clinical Trials
Assay Development
Biotechnology
Cmc Development
Protein Expression
Ind
Chromatography
Drug Discovery
Pharmaceutical Industry
Project Management
Certification
Colleagues
Nancy Potter
Quality Assurance Professional | Chief Marketing Officer | Oversight API Drug Substance
Ohad Amit
vice president & head biometrics at exelixis inc
Chris Senner
biotech cfo with commercial and operations experience
Dana Aftab
Chief Scientific Officer
Gisela Schwab
Executive Vice President | Chief Medical Officer
Other Named Weijun L.
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Weijun L. works for Exelixis
Weijun L.'s role in Exelixis is senior director biologics analytical development cmc lead at exelixis
Weijun L. works in the industry of Biotechnology Research
Weijun L.'s colleagues are Nancy Potter,Ohad Amit,Chris Senner
Weijun L.'s latest job experience is senior director biologics analytical development cmc lead at exelixis at Exelixis
