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Material Operations Senior Manager Biopharma CGT (Cell and Gene Therapies) is seeking a Senior Manager of Materials Operations to lead a team responsible for multiple GMP warehouses within Vertex’s internal Cell and Gene Therapy manufacturing network.
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At the newly designed Leiden Center 1 site in Boston Seaport and other greater Boston locations, Vertex envisions the growth of CGT pipelines research, development, and clinical manufacturing for emerging therapeutic modalities with the potential to treat and even cure Type I Diabetes.
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Company Overview: Our Client is a leading Contract Development and Manufacturing Organization (CDMO) specializing in the cell and gene therapy (CGT) sector. They offer comprehensive services from early-stage development through to commercial-scale manufacturing.
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Tasks include involvement in digital, analog, and RF design projects from initial bill-of-material selection through Printed Circuit Board (PCB) manufacturing, Circuit Card Assembly (CCA), and subsystem assembly including resolution on all technical and supplier related issues.
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Support tech transfer to third party manufacturing facilities for scale-up and production, including identifying and generating appropriate product specifications. Must be willing to travel to third party manufacturing sites.
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Lead and manage commercial QA oversight program including manufacturing, packaging and labeling, serialization, direct to practitioner sample program, third party logistics activities, to ensure compliance with DCSCA and associated regulatory requirements.
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Requirements Requires an advanced degree in Pharmaceutical Sciences, Chemistry, Materials Science, or related field with 5+ years of experience in process development and manufacturing of peptide and oligonucleotide APIs including PMOs. Experience with solid phase peptide/oligo synthesis preferred.
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Providing expert technical leadership in immunoassay reagent manufacturing process development. Lead the charge in bringing a novel ultrasensitive immunoassay platform to market, leveraging your expertise in process development to drive robust, scalable manufacturing processes.
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Interface with construction and manufacturing teams to ensure faithful and profitable execution of VBC projects. Works closely with VBC / Manufacturing Project Managers on project specific items.
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In close partnership with the Head of QA, as needed, oversee GMP, GLP and GCP compliance audits (US and international), including contract manufacturing sites, analytical testing sites, clinical storage and distribution sites, clinical investigator sites, contract test laboratories, and CROs to determine compliance status and to identify compliance risks.
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Assists in keeping the Pharmacy neat and clean by caring for equipment and cleaning after compounding prescriptions, manufacturing bulk medications, unit dosing, etc. Comprised of Tufts Medical Center, Lowell General Hospital, MelroseWakefield Hospital, Lawrence Memorial Hospital of Medford, Care at Home - an expansive home care network, and large integrated physician network.
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Fusion has a fully operational Good Manufacturing Practice (GMP) compliant state-of-the-art radiopharmaceutical manufacturing facility to meet supply demand for Fusion's growing pipeline of RCs.
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Ph. D. in biochemical engineering, chemical engineering, biochemistry, or appropriate technical discipline with 12-15 years industrial bioprocess development/scale-up and manufacturing experience.
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Innovive, a high-growth manufacturing company serving the Biomedical Research community is looking for Animal Care Technicians. This entry-level position reports to the Manager Vivarium Solutions, and is responsible for the daily care of research animals, including feeding, watering, cage changing, maintaining a clean work environment, and monitoring the overall health of the animals.
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Work with Preclinical Discovery BD group to continue servicing pre-existing clients into late stage API manufacturing and development. Strong understanding of the CMC and API/Small molecule manufacturing space for late stages.
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manufacturing job Company: Cybercoders in Boston, ID, France
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