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Supervisor - Engineering, Validation
Catalent Pharma Solutions LLC
Experience in cell therapy or gene therapy environments.
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Bulk Senior Principal Process Engineer
CSL Behring L.L.C.
Serve as the process SME for deviations, investigations, CAPAs, change controls, regulatory commitments, inspection support, startup issues, and equipment performance concerns.
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PTC Senior Principal Process Engineer
CSL Behring L.L.C.
Serve as the process SME for deviations, investigations, CAPAs, change controls, regulatory commitments, inspection support, startup issues, and equipment performance concerns.
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Senior Manager, Drug Substance Manufacturing Upstream
Ultragenyx Pharmaceutical
…hour schedule (7am-7pm). The roles primary focus will be on cell culture operations from vial thaw through to 2K operations for the production of viral particles for gene therapy…
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Senior Advisor, Separation Science - Analytical Development
Lilly
…closely with Lilly Genetic Medicines, Process and Formulation, Cell and Gene Therapy, and Quality teams to drive phase-appropriate analytical strategies and assay execution. The successful…
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Senior Advisor, Separation Science - Analytical Development
Eli Lilly and Company
…closely with Lilly Genetic Medicines, Process and Formulation, Cell and Gene Therapy, and Quality teams to drive phase-appropriate analytical strategies and assay execution. The successful…
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Sr. Manufacturing Associate, cGMP Manufacturing
Sumitomo Pharma America, Inc
Demonstrated knowledge of cGMP manufacturing principles, aseptic processing, and cleanroom operations within a regulated pharmaceutical or cell and gene therapy environment.
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Senior Scientist, Spatial Assays
Bristol Myers Squibb
Experience in oncology, immunology, autoimmune disease, cell therapy, gene therapy, or other advanced therapeutic areas preferred.
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Sr. Business Application Administrator (Costpoint SME)
Emmes Group
…scientific excellence, we’ve led groundbreaking research in cell and gene therapy, vaccines, infectious diseases, ophthalmology, rare diseases, and…
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Sr. Manager/Assoc Director, Manufacturing Sciences & Technology (MSAT)
Genezen
The field of gene therapy is growing rapidly and Genezen is here to meet the exacting needs of our clients. We provide process development, produce GMP viral vectors, and provide cell…
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Senior Scientist, Spatial Assays
JuN - Seattle Dexter
Experience in oncology, immunology, autoimmune disease, cell therapy, gene therapy, or other advanced therapeutic areas preferred.
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Manager of Non-Conformance - Root Cause Analysis/Deviations
Bristol Myers Squibb
Serve as the site SME and authority for root cause analysis methodology, ensuring all investigations are driven to true, defensible, and systemic root cause - never stopping at proximate or…
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Reimbursement & Medical Benefits Operations Supervisor
BLG Biologics, Inc.
Serve as reimbursement SME for Cell and Gene Therapy and broader Biologics medical benefit programs.
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Sr. IT Project Manager (NetSuite SME)
Emmes Group
…scientific excellence, we’ve led groundbreaking research in cell and gene therapy, vaccines, infectious diseases, ophthalmology, rare diseases, and…
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Senior Advisor, Bioassay Development - Analytical Development
Lilly
…closely with Lilly Genetic Medicines, Process and Formulation, Cell and Gene Therapy, and Quality teams to drive phase-appropriate analytical strategies and assay execution. The successful…
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Scientist, Preclinical Ophthalmology
Pharmaron
…leadership and project management for ocular drug, biologic, gene therapy, cell therapy, and medical device development programs. This role is responsible for designing, executing,…
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Manager, QC Microbiology - EM/UM 896 (Contract)
Vertex Pharmaceuticals
A minimum of 7 years of industry experience in Microbiology in a Biotechnology and/or Cell and Gene therapy organization.
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Sr. Principal Scientist, Quality Control
Lilly
The Sr. Principal Chemist is an individual contributor and site subject matter expert (SME) who supports new product introductions, commercialization, and ongoing commercial…
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Sr. Principal Scientist, Quality Control
Eli Lilly and Company
The Sr. Principal Chemist is an individual contributor and site subject matter expert (SME) who supports new product introductions, commercialization, and ongoing commercial…
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Executive Director, Immunology Sales
CSL Behring L.L.C.
…Affairs, Training, etc.) and is viewed as a Subject Matter Expert (SME) on Sales related issues and…
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CQV Manager
Legend Biotech US
…Bridgewater, New Jersey, we are advancing the next generation of cell therapy through a portfolio of innovative technologies, including autologous, allogeneic, and in vivo cell therapy…
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Scientific Associate Director, Analytical Sciences and Technology, Cell Therapy
Bristol Myers Squibb
Serve as the technical lead and SME for analytical method validation, transfer, lifecycle management, investigations, and performance optimization across Cell Therapy products.
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cGMP Compliance and Investigations Lead
J&J Family of Companies
Multiple years of progressive experience in the pharmaceutical, biotechnology, biologics, cell therapy, or gene therapy industry, including direct responsibility for cGMP investigations,…
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Director, Analytical Development
United Therapeutics
15+ years of biotech/pharma industry experience preferably in cell and gene therapy with a Bachelor's Degree in biological sciences, immunology, cell biology, biomedical or biochemical…
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Computer System Quality Validation Engineer
US WorldMeds
Must demonstrate understanding of cGMP's, industry and regulatory guidance, and multi-national biopharmaceutical/cell therapy regulations.
