Matthew Markert

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.

Country

United States

City

Edmonds

Industry

Biotechnology

Skill

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

Belenos Biosciences Inc.

Associate Director, CMC Program Management

Belenos Biosciences Inc.

LinkedIn
2026-4 - Present · 6 mos
AGC Biologics

CMC Project Manager

AGC Biologics

LinkedIn
2023-10 - 2026-3 · 2 yrs 6 mos

Seattle, WA

FUJIFILM Biotechnologies

CMC Project Manager

FUJIFILM Biotechnologies

LinkedIn
2022-1 - 2023-10 · 1 yr 10 mos
FUJIFILM Biotechnologies

Upstream Development Scientist

FUJIFILM Biotechnologies

LinkedIn
2018-10 - 2022-1 · 3 yrs 4 mos

Led upstream development of scalable cell culture processes through commercial readiness, authoring cGMP documentation and providing CMC technical guidance.

iBio, Inc.

Analytical Scientist

iBio, Inc.

LinkedIn
2016-10 - 2018-10 · 2 yrs 1 mo

College Station-Bryan Area

Managed lab operations, personnel, testing reports, and documentation for development of assays.

Education

Texas A&M Health Science Center

Texas A&M Health Science Center

LinkedIn

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.

Texas A&M University

Texas A&M University

LinkedIn

Microbiology, General

2009 - 2012 · 3 yrs

- Developed novel techniques for assaying caenorhabditis mating behavior - Collection and maintenance of caenorhabditis breeding lines

Matthew Markert's Contact Information

Email

******@***.com

Phone

(**) *** ****

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