Seth Levy

Seth Levy Email and Phone Number

Vice President of Manufacturing @ Modalis Therapeutics
Westborough, MA, US
Seth Levy's Location
Westborough, Massachusetts, United States, United States
Seth Levy's Contact Details

Seth Levy personal email

n/a

Seth Levy phone numbers

About Seth Levy

Creative process development leader driven by a passion for tackling R&D and CMC challenges, with a keen emphasis on improving manufacturing processes for Advanced Therapies. Expert knowledge of viral vector manufacturing with experience leading scientific teams spanning Analytical, Upstream and Downstream.

Seth Levy's Current Company Details
Modalis Therapeutics

Modalis Therapeutics

View
Vice President of Manufacturing
Westborough, MA, US
Website:
modalistx.com
Employees:
22
Seth Levy Work Experience Details
  • Modalis Therapeutics
    Vice President Of Manufacturing
    Modalis Therapeutics
    Westborough, Ma, Us
    View
  • Modalis Therapeutics
    Senior Director, Bioprocess Development
    Modalis Therapeutics Jul 2023 - Present
    Cambridge, Massachusetts, Us
    View
  • Modalis Therapeutics
    Director Of Bioprocess Development
    Modalis Therapeutics Jul 2021 - Jul 2023
    Cambridge, Massachusetts, Us
     Built and led internal Analytical, Upstream, and Downstream process development teams comprising 11 employees and three Managers, focusing on responsibility and accountability to successfully develop and tech transfer our internally developed manufacturing process to CDMO for scale up and clinical material supply. Supported corporate strategy and operations by planning facility design and construction and leading communications with potential partners to drive program management on time and on budget. Designed Regulatory CMC strategy and executed associated activities, including authoring CMC documentation for regulatory filings such as INTERACT and PreIND. Initiated External Innovation efforts for production and purification systems and analytical instrumentation, including perfusion production, small molecule production enhancers, novel purification resins, and mass photometry to drive process and product understanding of our novel gene therapy product. Orchestrated our Quality Management System, ensuring adherence to regulatory standards including developing procedures encompassing all aspects of QA and QC such as document management, personnel training, vendor qualifications, manufacturing, and analytical method Qualification. Developed clinical dosing strategies for AAV product by identifying Target Product Profile relevant attributes and considering clinical outcomes based on our established specifications for Drug Substance and Drug Product release and stability testing.
    View
  • Thermo Fisher Scientific
    Sr. Manager, Manufacturing Sciences
    Thermo Fisher Scientific Mar 2021 - Jul 2021
    Waltham, Ma, Us
    • As system owner of Technology Transfer and part of Site Leadership, I defined and implemented the procedures, systems, and practices for New Product Introduction (NPI), process validation, and continuous process verification in accordance with cGMP, ICH guidelines, and industry best practices.• Built and managed a team responsible for overseeing of Technology Transfer from Process Development or Clients to GMP Manufacturing by ensuring effective information flow, timeline execution, issue resolution, and documentation in accordance with governing Tech Transfer Quality standards.• Provided technical leadership to PD and GMP process engineers for early and late-stage clinical products by proactively communicating risks and recommending mitigation strategies to deliver “right first time” Tech Transfer and Operational execution.• Oversaw the design and execution of studies and investigations within process development and Manufacturing. Responsible for analyzing data to derive meaningful insights. Authored and/or reviewed the subsequent technical reports.• Performed technical review for internal and client project documents such as: tech transfer documents, development/process characterization/process validation plans, production/test records, summary reports, change controls and deviations.• FTE resource planning, budgeting, and justifications.• Drove global Tech Transfer alignment for Viral Vector Services between PD, GMP, and three cGMP manufacturing sites.• Mentored and developed staff on technical writing, investigation techniques, and regulatory concepts.
    View
  • Thermo Fisher Scientific
    Manager
    Thermo Fisher Scientific Jun 2019 - Mar 2021
    Waltham, Ma, Us
    • Built and led a team of ten employees, including two Supervisors, dedicated to molecular cloning, baculovirus generation, cell line development including single cell cloning (mammalian and insect cells) and cell line adaptation aimed at AAV and Lentivirus production. • Served as the Technical Project Lead (TPL) guiding clients through Process Development and Tech Transfer phases into the manufacturing of Phase I/II clinical materials.• Champion for “Operational Excellence” in continuous process improvement, process mapping, and site implementation of daily tiered management system.• FTE resource planning, budgeting, and justifications.• Small-Scale Development project lead for Process Development workstreams.• Assay Development project lead for Process Development workstreams.• Author and review SOPs, production records, development plans, and summary reports.• Routinely report on development data, and project progress. Provide insights into project direction and potential areas for optimization to both clients and internal leadership.• Guided team members to achieve their career and personal development goals through mentorship and tailored development plans.
    View
  • Brammer Bio
    Principal Scientist
    Brammer Bio Jun 2018 - Jun 2019
    Cambridge, Massachusetts, Us
    • Built and led a team of ten employees, including two Supervisors, dedicated to molecular cloning, baculovirus generation, cell line development including single cell cloning (mammalian and insect cells) and cell line adaptation aimed at AAV and Lentivirus production. • Served as the Technical Project Lead (TPL) guiding clients through Process Development and Tech Transfer phases into the manufacturing of Phase I/II clinical materials.• Champion for “Operational Excellence” in continuous process improvement, process mapping, and site implementation of daily tiered management system.• FTE resource planning, budgeting, and justifications.• Small-Scale Development project lead for Process Development workstreams.• Assay Development project lead for Process Development workstreams.• Author and review SOPs, production records, development plans, and summary reports.• Routinely report on development data, and project progress. Provide insights into project direction and potential areas for optimization to both clients and internal leadership.• Guided team members to achieve their career and personal development goals through mentorship and tailored development plans.
    View
  • Sanofi Genzyme
    Scientist
    Sanofi Genzyme Jan 2016 - Jun 2018
    Paris, France, Fr
    • Engineered novel gene therapy vehicles for muscle gene therapy approaches.• Establish protocols for non-human primate gene therapy studies. • Coordinated with contract manufacturing organizations for gene therapy vector production. • Established partnerships with contract research organizations to conduct non-human primate studies.• Responsible for Target-lead identification and validation of novel therapeutic approaches to inherited muscle diseases.
    View
  • Brigham And Women'S Hospital
    Postdoctoral Research Fellow
    Brigham And Women'S Hospital Sep 2014 - Jan 2016
    Us
    • Developed hydrogel drug delivery systems for treatment of inflammatory arthritis. • Established several surgical murine models including destabilization of the medial meniscus and partial meniscectomy to characterize therapeutic efficacy of osteoarthritis drugs. • Analyzed disease modifying effects of anti-rheumatic drugs in murine inflammatory arthritis models such as SKG and reactivation of the K/BxN models. • Succeeded in phenotyping bone composition in mouse genetic knockout models with altered osteoclast formation as well as explored osteoclast fusion mechanisms. • Managed contract research organizations (CROs) to further test and develop in vivo models. • Authored IACUC protocols and amendments to existing protocols.
    View

Seth Levy Skills

Vector Design Stem Cell Transplant Molecular Virology Cell Signaling Adeno Associated Virus Arthritis Bone Cartilage Inflammation Animal Models Animal Surgery Facs Vector Cloning Directed Evolution Stem Cell Research Adoptive Transfer Micro Computed Tomography Immunohistochemistry Elisa Multiplex Osteoclast Biology Biomaterials Recombinant Dna Recombinant Protein Therapy Mammalian Cell Culture Qpcr Gibson Assembly Primary Cell Isolation Pathology Histological Scoring Clinical Inflammation Scoring Flowjo Lymphocyte Characterization Myeloid Cell Characterization Gene Therapy Adenovirus Crispr In Vivo Research Cell Culture Molecular Biology Polymerase Chain Reaction Western Blotting Life Sciences Cell Biology Biochemistry

Seth Levy Education Details

  • University Of Alabama At Birmingham
    University Of Alabama At Birmingham
    Molecular And Cellular Pathology
  • University Of Massachusetts Amherst
    University Of Massachusetts Amherst
    Biochemistry And Molecular Biology

Frequently Asked Questions about Seth Levy

What company does Seth Levy work for?

Seth Levy works for Modalis Therapeutics

What is Seth Levy's role at the current company?

Seth Levy's current role is Vice President of Manufacturing.

What is Seth Levy's email address?

Seth Levy's email address is se****@****her.com

What is Seth Levy's direct phone number?

Seth Levy's direct phone number is +161725*****

What schools did Seth Levy attend?

Seth Levy attended University Of Alabama At Birmingham, University Of Massachusetts Amherst.

What are some of Seth Levy's interests?

Seth Levy has interest in Economic Empowerment, Education, Environment, Science And Technology, Animal Welfare, Health.

What skills is Seth Levy known for?

Seth Levy has skills like Vector Design, Stem Cell Transplant, Molecular Virology, Cell Signaling, Adeno Associated Virus, Arthritis, Bone, Cartilage, Inflammation, Animal Models, Animal Surgery, Facs.

Free Chrome Extension

Find emails, phones & company data instantly

Find verified emails from LinkedIn profiles
Get direct phone numbers & mobile contacts
Access company data & employee information
Works directly on LinkedIn - no copy/paste needed
Get Chrome Extension - Free

Aero Online

Your AI prospecting assistant

Download 750 million emails and 100 million phone numbers

Access emails and phone numbers of over 750 million business users. Instantly download verified profiles using 20+ filters, including location, job title, company, function, and industry.