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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. 15 plus years' experience in pharma/biotech industry with significant management experience in upstream/downstream process development and manufacturing of protein therapeutics.
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The Principal Scientist, Aseptic Control, is recognized as having expertise in the principals and application of sterile and low bioburden processing technologies and providing technical support for manufacturing of cell and gene therapy (C>), small molecule, and combination medical device programs within cCMP manufacturing.
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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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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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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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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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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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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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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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manufacturing job in Somerville, MA
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