Mark Yang Email & Phone Number

Waltham, Massachusetts, Us

• Develop and implement the corporate CMC strategies for biological products development• Process development, from cell line development, cell culture, purification, to fill/finish• Process scale up and technology transfer• Analytical assays development and qualification• GMP manufacturing, drug product fill finish, and label packaging• cCTD/IND authoring, submission, and timely approval• Clinical supply and trial support• CDMO management and business partnership development

Paris, France, Fr

• BLA authoring, submissions and commercial launches of Nexviazyme and Xenpozyme• ~10 IND/IMPD authoring, submissions, and approvals in US and EU • Recombinant protein and mAb drug product process development and GMP manufacturing• Manufacture process tech transfer, scale up, engineering runs, PV, PAI, and commercial launch• CMOs site inspection, contracting, tech transfer, and external manufacturing management• Platform process/formulation development and drug device incorporation• Commercial products GMP manufacturing tech support• Pilot process development facility design and construction• Management of cross functional project team for pipeline products development

Paris, France, Fr

• Phase III and commercial biotherapeutics process development and scale up • Commercial GMP products manufacturing tech support• Process improvement and life cycle management for commercial products• Tech support for cell culture and purification process development• Formulation and lyophilization process development and scale up• External CMO auditing, contracting (CDA, RfP, MSA, QTA), tech transfer, and GMP manufacturing• Raw material, container closure, and vendor qualification• IND, IMPD, briefing books, IB, pharmacy manual, and other CMC dossiers for regulatory submission • Assay development and managed a large Process Analytics Dept (interim head)

Cambridge, Ma, Us

• Built a drug product development lab and team from the ground up• Protein formulation development, container/closure, label/packaging, and process scale up• Lyophilization cycle development, robustness, and scale up • Biopharmaceuticals manufacture process tech transfer to partners/CMOs in US and EU• Author SOP, assay development and qualification, deviation investigation• Conducted more than a dozen on-site audits for CMO selection in US and EU • Supervised drug product fill-finish at CMOs; and drug substance GMP manufacturing • IND authoring and regulatory submissions• Clinical supply and clinical trial support

Deerfield, Illinois, Us

• Developed high concentration, up to 300 mg/ml, mAB formulation, and won the Outstanding Technical Achievement Award from Baxter Corp• Drug product manufacture process development and scale up• Excipient screening, formulation development, optimization, and forced degradation• Developed and optimized lyophilization processes for mAb and protein formulations• Antibody formulations characterizations, including injectability in vitro and in animals• Managed collaboration projects with external partners on drug formulation and delivery• Authored 2 patents on high concentration dosage development

Us

• Recombinant protein expression and optimization; expression process scale up to 1000L• Downstream purification process development and process scale up (>500g/run) • Large scale protein and intact mAb crystallization • High concentration crystal formulation development;• Tableting and controlled dosage development and characterization in GI model• Product stability and release assays including bioassay development

Bethesda, Md, Us

Expression and characterization of kinases and phosphatase in inositol phosphates signal transduction. Authored/coauthored 12 peer-reviewed research papers in many prestigious journals, including EMBO, JBC, Mol. Cell Biol. etc.

Athens, Ga, Us

Research projects include: Cloning and expression of thyrotropin genes and production of their mAbs, and Characterization of proteases and phospholipases in the acute cell death. Published 5 peer-reviewed research papers.

Ph.D., Pharmacology

M.S., Pharmacy

Bs, Microbiology