Michael Mercaldi

Michael Mercaldi Email and Phone Number

CMC Leader in Cell and Gene Therapy @ Torque Bio
Michael Mercaldi's Location
Greater Boston, United States, United States
Michael Mercaldi's Contact Details
About Michael Mercaldi

Process development leader that is passionate about developing drug products and the people that helps bring them to patients.

Michael Mercaldi's Current Company Details
Torque Bio

Torque Bio

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CMC Leader in Cell and Gene Therapy
Michael Mercaldi Work Experience Details
  • Torque Bio
    Vice President, Technical Operations
    Torque Bio Apr 2024 - Present
    Building out and leading Technical Operations function for TorqueBio, a next-gen AAV gene therapy company.
  • Oxford Biomedica
    Vice President, Strategy And Program Management
    Oxford Biomedica Jan 2023 - Apr 2024
    Oxford, Oxfordshire, Gb
    Leading the program, alliance and technical CMC management of our projects to bring one of the best AAV Platforms to our partners.Led the technical CMC management of our partner's projects to bring one of the best AAV Platforms to our partners. Helped to transition new organization from internal development (supporting only Homology) to a CDMO model (bringing our services to the broader marketplace). Key group accomplishments include: - Management of partners that included multiple pipeline programs and GMP manufacturing- Onboarding several new partners and helping to shepherd them from the non-clinical construct design phase toward scale up phase-Managing Strategic Alliances with key Development and Manufacturing Partners-Liasing with Business Development team to bring in new partners and showcase organizations capabilities-Defining internal capacity planning and price modeling.-Increasing organizational prowess to deliver on partner's project more efficiently and effectively
  • Oxford Biomedica
    Vice President Cmc Management & Purification And Drug Product Sciences
    Oxford Biomedica Mar 2022 - Jan 2023
    Oxford, Oxfordshire, Gb
    Transitioned from Homology to Oxford Biomedica Solutions as part of new JV between Homology and Oxford Biomedica. Led the technical CMC management of our partner's projects to bring one of the best AAV Platforms to our partners. Helped to transition new organization from internal development (supporting only Homology) to a CDMO model (bringing our services to the broader marketplace). Key group accomplishments included: - Management of a partners that included multiple pipeline programs and GMP manufacturing- Onboarding several new partners and helping to shepherd them from the non-clinical construct design phase toward scale up phase-Setting up Strategic Alliances with key Development and Manufacturing PartnersLed the Purification and Drug Product Sciences team which is responsible for AAV purification process development, formulation development and fill/finish development. Team has established one of the best end to end processes in the AAV space that can deliver high quality product for patients.Key group accomplishments included: - Development of a 2-8C stable formulation for AAV- Creation of a scalable, ultracentrifugation free purification process that delivered a high level of product purity
  • Homology Medicines, Inc.
    Senior Director , Downstream Process Development
    Homology Medicines, Inc. Feb 2018 - Mar 2022
    Led the Downstream Process Development group which is responsible for developing purification and drug product (formulation and fill/finish) processes for AAV therapeutics.Served as a CMC Team Lead. This team was responsible for delivering preclinical and clinical material supply and CMC product development strategy. Served as CMC representative on the program team to help manage the therapeutic through the development lifecycle.
  • Codiak Biosciences
    Director
    Codiak Biosciences Jun 2016 - Dec 2017
    Led the team in developing purification and formulation processes for exosome based therapeutics. Responsibilities also included co-developing and helping to manage organization's manufacturing outsourcing strategy.
  • Merrimack Pharmaceuticals
    Associate Director, Biologics Purification Process Development
    Merrimack Pharmaceuticals Jun 2013 - May 2016
    Cambridge, Massachusetts, Us
    Led the Purification Process Development Group
  • Medimmune
    Scientist Ii
    Medimmune Jun 2009 - Jun 2013
    Gaithersburg, Maryland, Us
    Developed purification processes for late stage (Phase II/III) monoclonal antibodies and other therapeutic proteins.
  • Tufts University
    Phd Candidate
    Tufts University Sep 2004 - May 2009
    Medford, Massachusetts, Us
    My research was focused on the development of natural biodegradable materials for using in biomedical applications. I was able to discover, isolate, and characterize a high molecular weight polysaccharide from a gram negative bacterium. Toward the end of my time at Tufts, I was in the process of developing a novel drug delivery system using this polysaccharide for the delivery of chemotherapeutics.
  • Pfizer
    Summer Intern
    Pfizer May 2003 - Aug 2003
    New York, New York, Us
    Summer Intern working on the development of Simulated Moving Bed (SMB) separations for small molecules drug candidates.
  • Pfizer
    Summer Intern
    Pfizer May 2002 - Aug 2002
    New York, New York, Us
    Summer Intern working on the development of Simulated Moving Bed (SMB) chromatography separations for the purification of potential drug candidates
  • Regeneron Pharmaceuticals
    Summer Intern
    Regeneron Pharmaceuticals May 2001 - Aug 2001
    Tarrytown, New York, Us
    Worked on the development of purification processes for protein therapeutics.

Michael Mercaldi Skills

Purification Chromatography Biotechnology Hplc Protein Purification Technology Transfer Sds Page Biochemistry Elisa Western Blotting Drug Delivery High Performance Liquid Chromatography Mammalian Cell Culture Biomaterials Bacterial Cell Culture Protein Expression Filtration Pat Design Of Experiments Light Scattering Nanoparticles Nanotechnology Controlled Release Protein Engineering Quality By Design

Michael Mercaldi Education Details

  • Tufts University
    Tufts University
    Chemical Engineering
  • Rensselaer Polytechnic Institute
    Rensselaer Polytechnic Institute
    Chemical Engineering

Frequently Asked Questions about Michael Mercaldi

What company does Michael Mercaldi work for?

Michael Mercaldi works for Torque Bio

What is Michael Mercaldi's role at the current company?

Michael Mercaldi's current role is CMC Leader in Cell and Gene Therapy.

What is Michael Mercaldi's email address?

Michael Mercaldi's email address is me****@****hoo.com

What is Michael Mercaldi's direct phone number?

Michael Mercaldi's direct phone number is (617) 949*****

What schools did Michael Mercaldi attend?

Michael Mercaldi attended Tufts University, Rensselaer Polytechnic Institute.

What skills is Michael Mercaldi known for?

Michael Mercaldi has skills like Purification, Chromatography, Biotechnology, Hplc, Protein Purification, Technology Transfer, Sds Page, Biochemistry, Elisa, Western Blotting, Drug Delivery, High Performance Liquid Chromatography.

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