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The incumbent will provide Automation support to the daily operations, continuous improvement, and projects for the Pilot Plant, Bulk Manufacturing, Filling, Assembly, Packaging, Utilities, Facilities, and other DCS and PLC Automated Equipment and Control Systems on a GMP regulated environment.
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Experience with Tech transfer to CDMO for non-GMP and GMP manufacturing, including cell line development, process development, analytical method development and manufacturing scale up. Experience with Tech transfer to CDMO for non-GMP and GMP manufacturing, including cell line development, process development, analytical method development and manufacturing scale up.
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Project lead for establishing Pilot Plant operations including building out the team to support process scale-up, implementation of new processes, and execution at GMP scale. Optimize pilot plant and pre-clinical production performance to allow for fast, flexible processing of multiple manufacturing processes including plasmid DNA prep, mRNA transcription and purification, and LNP formulation, and oligonucleotide synthesis.
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The group supports non-GMP transient protein lead production across the company's diverse biotherapeutic discovery portfolio to enable the research units and their pre-clinical therapeutic in-vitro and in-vivo needs.
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Skills: HPLC, SOP, In Vitro, In Vivo, Protein Purification, GMP (Good Manufacturing Practice) The purification group is responsible for non-GMP protein- drug lead generation, supporting the various company research units and their pre-clinical therapeutic in- vitro and in- vivo needs.
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Minimum of five years of progressive experience in a clinical laboratory or GMP Cell Therapy Lab, and a minimum of three years of teaching experience in an accredited program. The Cell Therapy GXP Educational Program Director is a key leadership position that will develop and implement the Cell Therapy GXP Workforce Training Program (WTP) within Dana-Farber Cancer Institute.
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About Insourcing Solutions Charles River Insourcing Solutions℠ can streamline research by delivering operational and cost efficiencies through the strategic insourcing of GMP, GLP and non-GLP research services from discovery through safety assessment.
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Bachelors, or Masters, degree in a technical discipline (Biology/Molecular Biology/Chemistry or related field) with a minimum of 3 years of experience, or 2 years with Masters degree, preferably in a GMP QC laboratory setting.
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PRODUCTS: Laboratory reagents: antibodies, ELISA kits, RUO and GMP recombinant proteins, nanobody reagents, single-cell RNA seq assaysCUSTOMERS: Pharmaceutical, Therapeutic & Biotechnology CompaniesKey Responsibilities:Design and implement your sales strategy for the region.
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Our Pivotal Attribute Sciences Department plays a crucial role in pivotal phase analytical development, including method development, validation, transfer, process and product development support, and GMP testing of drug substances and drug products.
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As a CMC development lead, the individual will apply their strong expertise in CMC fermentation and/or purification to develop robust, phase-appropriate processes for drug substance GMP production to enable human clinical studies and eventual licensure.
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The incumbent will perform all the following as a member of an interdisciplinary team, inclusive of a cyclotron engineer, radiochemists, GMP production staff, and nuclear pharmacists. Perform routine manufacturing processes in support of PET GMP production runs.
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This position will oversee the QC function and support the development and implementation of GMP quality systems to ensure that Sanofi’s testing and control strategies are in compliance with Sanofi policies, US and international regulations, laws, and guidelines that oversee the manufacturing and testing of investigational clinical trial materials.
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Establish key metrics; regularly communicate reports to key internal stakeholders to evaluate the effectiveness of Xenon’s QMS. Support Quality Management Review activities and oversee trending of key GMP quality management system performance metrics.
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Kudo has a state-of the-art clinical GMP manufacturing facility and Manufacturing Sciences & Analytical Technology (MSAT) laboratories in Shanghai, China, as well as a Process Science Center of Excellence in Needham, MA, where Kudo operates mRNA/LNP process and analytical development labs.
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gmp job in Waltham, MA
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