Vice President, Technical Operations
CurrentBuilding out and leading Technical Operations function for TorqueBio, a next-gen AAV gene therapy company.
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Michael Mercaldi is listed as CMC Leader in Cell and Gene Therapy at Torque Bio, based in Greater Boston, United States. AeroLeads shows a work email signal at faa.gov, phone signal with area code 617, 580, and a matched LinkedIn profile for Michael Mercaldi.
Michael Mercaldi previously worked as Vice President, Technical Operations at Torque Bio and Vice President, Strategy and Program Management at Oxford Biomedica. Michael Mercaldi holds Ph.D., Chemical Engineering from Tufts University.
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Process development leader that is passionate about developing drug products and the people that helps bring them to patients.
Listed skills include Purification, Chromatography, Biotechnology, Hplc, and 21 others.
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Building out and leading Technical Operations function for TorqueBio, a next-gen AAV gene therapy company.
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, 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
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.
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.
Cambridge, Massachusetts, Us
Led the Purification Process Development Group
Gaithersburg, Maryland, Us
Developed purification processes for late stage (Phase II/III) monoclonal antibodies and other therapeutic proteins.
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.
New York, New York, Us
Summer Intern working on the development of Simulated Moving Bed (SMB) separations for small molecules drug candidates.
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
Tarrytown, New York, Us
Worked on the development of purification processes for protein therapeutics.
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Michael Mercaldi works for Torque Bio.
Michael Mercaldi is listed as CMC Leader in Cell and Gene Therapy at Torque Bio.
AeroLeads has found 1 work email signal at @faa.gov for Michael Mercaldi at Torque Bio.
AeroLeads has found 2 phone signal(s) with area code 617, 580 for Michael Mercaldi at Torque Bio.
Michael Mercaldi is based in Greater Boston, United States while working with Torque Bio.
Michael Mercaldi has worked for Torque Bio, Oxford Biomedica, Homology Medicines, Inc., Codiak Biosciences, and Merrimack Pharmaceuticals.
You can use AeroLeads to view verified contact signals for Michael Mercaldi at Torque Bio, including work email, phone, and LinkedIn data when available.
Michael Mercaldi holds Ph.D., Chemical Engineering from Tufts University.
Michael Mercaldi is listed with skills including Purification, Chromatography, Biotechnology, Hplc, Protein Purification, Technology Transfer, Sds Page, and Biochemistry.
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