Weijun L. Email and Phone Number

- Develop antibody-drug conjugates (ADC) and bispecific antibodies for cancer therapy.- Build and direct the analytical/QC team for the biologics product portfolio.- Strategize and accountable for ADC development projects as the CMC Team Leader. - Select and manage the biologics CDMO network and relevant development and manufacturing contracts. - Manage CMC project budget, team resource planning, and cross functional alignment.

- Direct all aspects of CMC analytical activities (AK002 Lirentelimab late-stage development and other early development candidates), including in-house assay development, process analytics and external CMO/CTL management for both GMP QC and non-GMP development.- Set the strategy for product release testing, specification, stability study and product characterization; drive the analytical validation and transfer.- Assess high level CMC strategy and timeline alignment for late-stage antibody product development for multiple indications.- Support the DS/DP process development, process characterization, PPQ, tech transfer, validation and manufacturing.- Direct GLP bioanalytical program (pharmacokinetic and immunogenicity) for non-clinical studies and clinical trial.- Oversee QC support for investigational product supply to clinical sites under GCP regulation. - Set up and coach a highly motivated ADQC team (10 FTEs) in a fast-paced environment.

- Managed a technical support group representing 4 products: Kogenate®FS, Kovaltry®, Leukine® and JIVI® in QC. - Provided leadership and technical oversight for the successful transfer of commercial analytical methods for capacity expansion, facility replacement or commercial launch. Supported the process transfer comparability protocol and studies. Oversaw the GMP contract testing for client company (Sanofi, Leukine®).- Supported the analytical method life cycle management including post-approval change for QC methods such as potency, glycan analysis, mycoplasma rapid testing, etc. Supported method development and validation. Authored/reviewed CMC technical registration documents for regulatory submissions. Owned the product specification documents. Managed the QC overarching SOPs such as OOS and lab discrepancy, critical reagents, instrument PQ, specification setting, method validation, etc.- Oversaw the QC departmental metrics including invalid events, OOS/unexpected results, deviations, CAPA, change control, etc. Drove the implementation of Bayer Compliance Management System (CMS).- Represented QC in Berkeley Site Compliance Council and led QC GMP inspections and audits by health authorities (FDA, EMA, MFDS, PMDA, CBS, etc.), internal auditors and external partners. Supported regulatory responses to Deficiency Letters, Annual Product Review, and global product license application (BLA in major countries and IMEM).- Represented QC in the continued process verification (CPV) and various manufacturing operation meetings. Reviewed and approved assigned special studies including device compatibility studies, in-process control, cold chain, or other process improvement/validation related protocols/reports.- Managed the statistical support program in QC.- Provided effective leadership including individual goal setting, performance review, motivating and developing employees, mitigating conflicts, and supporting workforce diversity and quality.

A group leader and project manager in Analytical Development and Validation, Global Biological Development Organization.Supported the CMC analytical development of more than 10 biologic products for clinical trials in a clinical ADQC function. Contributed to the BLA/MAA and approval of Kovaltry and Jivi for hemophilia therapy. Expert understanding of the phase appropriate development strategy in a development QC environment (GMP).Role #1: Head of Chemistry, Protein Chemistry & Raw Material Assay Development Group. Role #2: Analytical Development Representative for three CMC development projects including BAY109 mAb (member of global Technical Development Teams).

Member of the Liposome Project Team in Hematology& Cardiology Business Unit.Technical oversight of QA/QC issues and contract manufacturing of clinical development product. Experience with the combination product (KG-Lip).

Research in DNA and oligonucleotide delivery, liposome formulation, PEGylation of peptides and lipids, in vitro and in vivo study, etc..