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Hands-on protein purification and downstream process development at scales from 0.1-50 L. Experience with lyophilization and/or spray dry process development. Characterizing in-process and purified proteins to support process development, including SDS-PAGE, UV-Vis, colorimetric assays, HPLC, SEC-MALS, DLS, etc.
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Cross-train on and provide support for upstream and downstream process development operations. Regeneron's Viral Production Core (VPC), part of the Preclinical Manufacturing and Process Development (PMPD) group is looking for a Process Development Engineer I- VPC Analytics , responsible for analytical support for manufacturing process development functions.
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The Analytical Development Senior Scientist position is a technical position responsible for supporting Analytical and Process Development with early and late phase LC methods including process residuals and physiochemical chromatography (size exclusion, ion-exchange, reversed phase, hydrophobic interaction, etc.
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Process Development, Stability and Characterization analytical support, optimization, and qualification in a range of analytical techniques including U/HPLC, capillary and plate based techniques.
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You will have exposure to all stages of process development: from discovery to manufacturing technology transfer. Comfortable with process development or engineering including at pilot and production scale.
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Lead and / or assist in the development and execution of process and facility monitoring strategies that focus on areas of highest microbial risk (e.g., disinfectant/sanitizing agent evaluation, resident microflora evaluation, airflow pattern testing, environmental monitoring PQ, aseptic process simulations, etc.
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Will propose and organize pilot plant or plant trials, interpret the results, and assist process development; will be responsible for writing well-structured thorough reports, with proper conclusions and recommendations.
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The Bioconjugation Process Development Director is responsible for the process development and manufacturing of large molecule bioconjugates for biotherapeutics, with a focus on Antibody Drug Conjugates (ADCs.
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Execution of formulation, process development and stability studies for gene therapy programs. The candidate will be a part of the Biologics Drug Product Development team in support of Gene Therapy programs in the Genomic Medicine Unit. The incumbent will have the opportunity to work on different facets of drug delivery and product development for modalities such as Lipid Nanoparticles (LNPs) and Adeno-associated virus (AAV.
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Senior Scientist/Principal Scientist, Formulation and Process Development. Ph. D. preferred in Chemistry, Biochemistry, Bioengineering, or Pharmaceutical Sciences with a minimum of 5-8+ years in design and development of nanoparticle-based drug delivery systems or complex biologics.
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This position will work with a label translation company to supplement the phrase library as required and will work with the CSO Continuous Improvement function to establish industry-leading label development process that incorporates global regulatory requirements while incorporating flexibility and simplicity in the design of clinical labels.
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As an Associate Scientist in our Manufacturing Sciences Scale Up Lab (SUL), you will be responsible for the production of cell culture and microbial materials for development, toxicology, and process scale-up studies in a non-GMP environment.
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The incumbent will be part of the Viral Vector Product Development Leadership Team in defining overall strategy, team growth, budgeting, and providing expertise to project team on all aspects of downstream process development.
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Experience in the sterile drug product development (preformulation, formulation, process development and GMP fill/finish). BS or MS with at least 6 years of related industry experience OR a PhD with at least 3 years of related industry experience in Pharmaceutical Sciences, Bio/Chemical Engineering, Chemistry, Biochemistry or related major.
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Support process development and regulatory filings by authoring protocols, reports, and CMC regulatory sections. He/she will work collaboratively in a cross-functional team on a range of innovative pipeline programs and develop state-of-art methods and technologies to support process development and regulatory filings.
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