Matthew Markert
Associate Director, CMC Program Management @ Belenos Biosciences Inc.
About
Technical CMC Project Leader with 9+ years of CDMO/CMO experience directing Antibody and Cell & Gene Therapy (CGT) Drug Substance programs through the full product lifecycle. I specialize in leading high-complexity CMC projects through tech transfer (Phase I, II, and III), process characterization (PC), PPQ, and commercial launch. My expertise lies in integrating cross-functional inputs from PD, MSAT, and Quality to maintain rigorous timelines while ensuring regulatory readiness for IND, BLA, and MAA filings across global markets, including North America (US/Canada), EU, and China/APAC. I am passionate about driving operational excellence, saving costs, and fostering a culture of accountability and problem-solving.
United States
Edmonds
Biotechnology
Business Alignment, Business Relationship Management, Project Implementation, Cell Therapy, Life Sciences, Product Development, Leadership, Biotechnology Industry, Program Management, Bacterial cell culture, Antibodies, Cell and Gene Therapy, Microsoft Project, Smartsheet, Regulatory Submissions, Milestone Delivery, Financial Forecasting, Stakeholder Management, Minutes, Vendor Management
Experience
Education

Medical Sciences
- Developed and optimized CRISPR/Cas9 protocols for both in vivo insect microinjection and in vitro mammalian cell transfection. - Designed, assembled, and validated plasmid constructs for BAC recombination and mammalian chromosomal targeting. - Maintained, passaged, and transfected a variety of mammalian cell lines in support of genetic engineering studies. - Conducted routine viral infection studies in guinea pigs, including blood collection, necropsy, and organ harvesting. - Performed high-throughput PCR genotyping assays to support screening and validation of engineered constructs. - Managed care, breeding, and experimental use of a Monarch butterfly colony. - Parsed, analyzed, and summarized large microarray datasets using advanced Microsoft Office tools to support data-driven conclusions. - Trained, supervised, and mentored undergraduate and graduate student researchers, including rotational students, ensuring adherence to protocols and data quality standards.
Matthew Markert's Contact Information
Phone
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