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Process development leader that is passionate about developing drug products and the people that helps bring them to patients.
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Vice President, Technical OperationsTorque Bio Apr 2024 - PresentBuilding out and leading Technical Operations function for TorqueBio, a next-gen AAV gene therapy company. -
Vice President, Strategy And Program ManagementOxford Biomedica Jan 2023 - Apr 2024Oxford, Oxfordshire, GbLeading 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 -
Vice President Cmc Management & Purification And Drug Product SciencesOxford Biomedica Mar 2022 - Jan 2023Oxford, Oxfordshire, GbTransitioned 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 -
Senior Director , Downstream Process DevelopmentHomology Medicines, Inc. Feb 2018 - Mar 2022Led 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.
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DirectorCodiak Biosciences Jun 2016 - Dec 2017Led 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.
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Associate Director, Biologics Purification Process DevelopmentMerrimack Pharmaceuticals Jun 2013 - May 2016Cambridge, Massachusetts, UsLed the Purification Process Development Group -
Scientist IiMedimmune Jun 2009 - Jun 2013Gaithersburg, Maryland, UsDeveloped purification processes for late stage (Phase II/III) monoclonal antibodies and other therapeutic proteins. -
Phd CandidateTufts University Sep 2004 - May 2009Medford, Massachusetts, UsMy 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. -
Summer InternPfizer May 2003 - Aug 2003New York, New York, UsSummer Intern working on the development of Simulated Moving Bed (SMB) separations for small molecules drug candidates. -
Summer InternPfizer May 2002 - Aug 2002New York, New York, UsSummer Intern working on the development of Simulated Moving Bed (SMB) chromatography separations for the purification of potential drug candidates -
Summer InternRegeneron Pharmaceuticals May 2001 - Aug 2001Tarrytown, New York, UsWorked on the development of purification processes for protein therapeutics.
Michael Mercaldi Skills
Michael Mercaldi Education Details
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Tufts UniversityChemical Engineering -
Rensselaer Polytechnic InstituteChemical 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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