Mark Yang

Mark Yang Email and Phone Number

Vice President of CMC at Palleon Pharmaceuticals @ Palleon Pharmaceuticals
Mark Yang's Location
Greater Boston, United States, United States
Mark Yang's Contact Details
About Mark Yang

Mark Yang is a Vice President of CMC at Palleon Pharmaceuticals at Palleon Pharmaceuticals. He possess expertise in formulation, technology transfer, protein chemistry, gmp, lyophilization and 6 more skills.

Mark Yang's Current Company Details
Palleon Pharmaceuticals

Palleon Pharmaceuticals

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Vice President of CMC at Palleon Pharmaceuticals
Mark Yang Work Experience Details
  • Palleon Pharmaceuticals
    Vice President Of Cmc
    Palleon Pharmaceuticals Feb 2021 - Present
    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
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  • Sanofi
    Director, Global Pharmaceutical Development Biologics
    Sanofi Aug 2016 - Jan 2021
    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
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  • Sanofi
    Director, Fill Finish Development/Late Stage Process Development
    Sanofi Jul 2011 - Aug 2016
    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)
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  • Acceleron Pharma
    Associate Director, Formulations
    Acceleron Pharma Nov 2007 - Jul 2011
    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
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  • Baxter
    Project Leader/Res Scientist
    Baxter Sep 2005 - Oct 2007
    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
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  • Altus Pharmaceuticals
    Sr. Staff Scientist
    Altus Pharmaceuticals 2000 - 2005
    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
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  • National Institutes Of Health
    Irta Fellow
    National Institutes Of Health 1996 - 1999
    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.
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  • University Of Georgia
    Research Associate Then Graduate (Ms And Phd) Student
    University Of Georgia 1990 - 1996
    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.
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Mark Yang Skills

Formulation Technology Transfer Protein Chemistry Gmp Lyophilization Sop Ind Drug Development Fda Biotechnology Protein Characterization

Mark Yang Education Details

  • The University Of Georgia
    The University Of Georgia
    Pharmacology
  • The University Of Georgia
    The University Of Georgia
    Pharmacy
  • Northwestern University, China
    Northwestern University, China
    Microbiology

Frequently Asked Questions about Mark Yang

What company does Mark Yang work for?

Mark Yang works for Palleon Pharmaceuticals

What is Mark Yang's role at the current company?

Mark Yang's current role is Vice President of CMC at Palleon Pharmaceuticals.

What is Mark Yang's email address?

Mark Yang's email address is ma****@****ofi.com

What is Mark Yang's direct phone number?

Mark Yang's direct phone number is +161725*****

What schools did Mark Yang attend?

Mark Yang attended The University Of Georgia, The University Of Georgia, Northwestern University, China.

What skills is Mark Yang known for?

Mark Yang has skills like Formulation, Technology Transfer, Protein Chemistry, Gmp, Lyophilization, Sop, Ind, Drug Development, Fda, Biotechnology, Protein Characterization.

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