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Author technical reports and analytical Chemistry, Manufacturing and Controls (CMC) sections in regulatory documents. Lead analytical method development for synthetic small molecules, synthetic peptide, and/or SiRNA manufacturing, release testing and characterization.
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Direct the planning and implementation of process development, scale-up, technology transfer, and validation efforts in drug substance manufacturing, ensuring strategic alignment and operational excellence.
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Demonstrate basic knowledge of the GXP cellular therapy product manufacturing, and program development and evaluation, as well as needs assessment and marketing of the programWorking knowledge of flow cytometry, molecular biology, and genetic engineering is a plus.
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Act as the key contact to SQF practitioner, OSHA and for all plant manufacturing practices & maintenance. Contact: John@SourceRecruitmentSolutions.com Our client, a premier Food Manufacturing Company with products sold nation wide is seeking an experienced Quality Assurance Manager.
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Qualified candidates must have a PhD in synthetic/organic chemistry or related scientific field with 15+ years’ experience in drug substance development and manufacturing and a proven track record in developing and scaling up chemical process to kilo lab, pilot plant and commercial plant scales.
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Extensive experience selecting and overseeing CDMO’s for tech transfer of protein manufacturing including both upstream and downstream methods. Tech transfer of methods and processes to CDMO for early stage clinical manufacturing.
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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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Minimum 8 years of experience in GMP-regulated sterile drug product manufacturing and validation, with a focus on biologics, lyophilization, and fill/finish operations in CMC late-stage development within the biotech/pharmaceutical industry.
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In health, we focus on areas like medical countermeasures, advanced therapeutics, regenerative medicine, cell and gene therapies, biologics manufacturing, natural products, APIs and KSMs, enzymes, biocatalysis, and microbiome therapy to support national health security and public health initiatives.
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This breakthrough allows for unprecedented data collection and scalability in cell biology research, drug development, and pharmaceutical manufacturing. Define and implement manufacturing and test processes for PCBA sub systems.
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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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Its patent-pending and proprietary pluripotent stem cell differentiation technology platform TFomeTM was developed in Professor George Church’s lab, a pioneer in synthetic biology, and allows for the development of unique cell therapies with significantly streamlined manufacturing, improved cell quality, efficiency and speed.
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Hands-on knowledge of cGMP and CMC regulatory requirements for cell or gene therapy manufacturing. As we strive to halt degenerative diseases, we seek talented CMC leadership to lead tech transfer to our late-phase and commercial CDMO, manage DP production for our Phase III trials, prepare the CMC strategy for BLA submission, and build a manufacturing organization for commercialization.
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Develop and optimize upstream and downstream processes to generate lead and Development Candidate TCR bispecific and to enable seamless technology transfer to contract manufacturing organizations.
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As a Staff Battery Engineer, you'll use your expertise to collaborate with experts in materials, electrochemical testing, design, process, manufacturing to drive performance of our first and next-generation electrodes.
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manufacturing job in Cambridge, MA
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