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You will provide expertise for the scale-up, tech transfer, and validation of upstream cell culture and viral vector unit operations in support of clinical/commercial manufacturing. This role will be key in supporting vaccine tech transfer and process development.
ExpandApply NowActive JobUpdated 11 days ago - UpvoteDownvoteShare Job
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Provide support for client Tech Transfer schedules by assisting with Apheresis scheduling and ordering of necessary materials. Collaborate with the warehouse team to streamline the kitting process for early Tech Transfer runs, ensuring accurate and timely delivery of materials.
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Collaborate cross-functionally with other departments including process engineering, tech transfer, drug substance, and analytical development. The candidate will help with clients` tech transfer operations as well as support new process development proposals and initiatives for clients.
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Required skills: Design bioreactor scale-up strategy; research and develop viral vector process; plan and define tech transfer activities such as bill of materials, protocol transfer process, and gap assessment; multi-scale bioreactor hands-on experience 0.5L - 1000L; analyze process analytical technology (PAT) trends and implementation; Raman, Aber probe, etc.
Full-timeExpandApply NowActive JobUpdated 30 days ago - UpvoteDownvoteShare Job
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Basic knowledge of cell culture manufacturing principles, risk assessments (FMEA), Chemistry, Manufacturing, and Controls (CMC) principles, and tech transfer. GC Therapeutics equal employment opportunity policy applies to all terms and conditions of recruiting, hiring, placement, training, compensation, transfer, leave of absence, employment, promotion, layoff and termination of employment.
Full-timeExpandApply NowActive JobUpdated 28 days ago - UpvoteDownvoteShare Job
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OOS investigations, OOS, Tech transfer, HPLC, FTIR, Analytical chemistry, GC, UV-VIS, UVVIS, Karl Fisher, Method development, validation, quality control, Wet chemistry, GC Analyzer, GC Analysis, titrations.
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As part of SMDD, this role also provides connectivity to the diverse technical expertise, experience, and resources from the SMDD development group in Indianapolis, IN. Candidates for this position will also provide oversight for external R&D and tech transfer to other functions within Eli Lilly as necessary.
Full-timeExpandApply NowActive JobUpdated 8 days ago - UpvoteDownvoteShare Job
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Work with cross-functional teams to drive execution of key launch/tech transfer deliverables and produce required documentation (VMP, PPQ protocol, PPQ report, etc.) This involves the startup of a new commercial manufacturing site, technology transfer, and process validation.
ExpandApply NowActive JobUpdated 16 days ago - UpvoteDownvoteShare Job
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Fundamental understanding and application of technology transfer and validation processes. The Process Engineering Manager will report to the Director of Manufacturing Science and Technology (MSAT.
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The successful candidate will lead and oversee formulation-drug product process development, tech transfer, and manufacturing with external development and manufacturing partners; in addition to leveraging Cerevel's internal formulation development capabilities as well as a growing array of analytical and physical characterization instruments.
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Job Overview: This position involves leading process development, tech transfer, and manufacturing activities for our clients novel oncology platform collaborating with various internal and external stakeholders, and contributing to the development of promising early and late stage therapeutics.
Full-timeExpandApply NowActive JobUpdated 7 days ago - UpvoteDownvoteShare Job
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They will be a key interface with other drug discovery and development scientists as well as stakeholders across the organization from clinical, translational medicine, CMC, regulatory, commercial, and analytical for the tech transfer and development of new products and functions within our company as well as with external academic and industrial partners.
Full-timeExpandApply NowActive JobUpdated 24 days ago - UpvoteDownvoteShare Job
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Provide QA Validation support and expertise to CMC and Tech Transfer teams. Provide quality guidance on process qualification, and continuous process verification strategies for gene editing components (i.e., oligonucleotide guide, CRISPR endonuclease, and ribonucleoprotein [RNP] complex) and ex vivo CRISPR gene-edited cell therapies manufactured internally and at CMOs.
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Demonstrated experience working directly with or overseeing CDMOs or experience as Person in Plant is required along with a strong foundation in process development and tech transfer. Interact with contract manufacturers and development organizations as a representative driving external development, tech transfer, and clinical manufacturing activities.
ExpandApply NowActive JobUpdated 15 days ago - UpvoteDownvoteShare Job
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Provide support with tech transfer activities for manufacturing of drug product. Generate high quality documentation in support of regulatory filings and tech transfer. The candidate will work on formulation and scale up of lipid nanoparticles (LNPs) and other non-viral delivery matrices targeting different organs and cell types for a variety of therapeutic applications.
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tech transfer jobs in Waltham, MA
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