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Support and closely work with research, cell-line development, upstream, downstream, and analytical scientist. The formulation scientist will work closely with downstream and analytical scientists to analyze biochemical and biophysical properties for biopharmaceutical products.
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The Director, Manufacturing Operations will oversee, lead Upstream & Downstream operations; manage process/cleaning validation, scale up & technology transfer; direct personnel for efficient use of equipment in accordance with the production plan; as well as be responsible for the costing & budgeting for the products manufactured by Kashiv Biosciences LLC.
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Hands on work will be required in small and large scale including, but not limited to, upstream, downstream, conjugation, formulation and lyophilization processes as needed. Assist senior staff in experiments designed to develop new or improve existing upstream, downstream, conjugation and formulation processes and investigate problems related to biological products, as required.
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BPR&D includes three lab-facing technical functional areas: Process Cell Sciences (PCS), Upstream and Downstream Process Development & Engineering. We are actively looking for highly motivated people with a passion for innovation and interest in contributing to upstream and/or downstream bioprocessing.
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Upstream Knowledge of recombinant protein expression, metabolic pathways, biochemistry, and cell culture Understanding of basic bioreactor principles, mass transfer kinetics Understanding of cell & molecular biology.
$111,400 - $175,300 a yearExpandUpdated Yesterday - UpvoteDownvoteShare Job
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In addition to the required skillsets above, relevant experience is needed in either upstream and/or downstream bioprocessing as described below. Knowledge of protein biochemistry, biophysics, conjugation techniques.
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Prior experience in relevant area to own domain (e.g., upstream/downstream cGMP experience, process development, HPLC/biological assays) strongly preferred. Minimum Requirement: Bachelor's degree with 7+ years experience in relevant scientific area (e.g., GMP: chemistry, biology, chemical engineering, analytical chemistry, biotechnology; ECTL: cellular biology, molecular biology, immunology, biochemistry.
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The Manufacturing Supervisor may be assigned to work directly with Upstream, Downstream or Buffer Preparation Unit Operations. Masters degree in Biology, Microbiology, Chemistry, Biochemistry, Engineering, or related field and 3+ years of experience in a manufacturing environment; OR.
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Communicate outcomes of key meetings to stakeholders and functional areas (i.e., stage gates, working group meetings – upstream, downstream, analytical, shipping logistics). PhD PhD in chemistry, biochemistry, pharmaceutics or related disciplines in the pharmaceutical/biotechnology sciences with at least 5 years of industry experience.
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The role will work closely with process development and technical transfer and manufacturing staff to meet upstream and downstream outcomes including in-process, release and stability testing, leading assay development and validation and driving quality control documentation and investigations.
$74,859.2 - $112,195.2 a yearExpandUpdated Today - UpvoteDownvoteShare Job
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Perform hands-on experimental work in the early-phase development and optimization of upstream (cell culture and transfection conditions) and downstream (clarification, chromatography, tangential and normal flow filtration) unit operations for viral vector production.
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Industry experience with early discovery and development of vaccines including optimization of upstream/downstream technologies that include benchtop fermentation, adjuvant selection and optimization, familiarity with in-process and potency assay design and development.
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Bachelor's Degree Bachelor's degree in chemistry, biochemistry, pharmaceutics or related disciplines in the pharmaceutical/biotechnology sciences and at least 7 years of industry experience. - 4 or More Years Ph. D. in chemistry, biochemistry, pharmaceutics, or related disciplines within pharmaceutical/biotechnology sciences with at least 5 years of industry experience preferred.
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They will collaborate with various internal functions including Analytical, Upstream/Downstream Manufacturing, Quality Control, Quality Assurance, Regulatory, and Supply Chain to ensure best practices are implemented and followed at external contract manufacturing and testing labs, and internally at Leap Therapeutics.
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Familiarity with upstream or downstream process operations, such as cell culture, centrifugation, depth filtration, tangential-flow filtration, and/or chromatography with expertise in at least one functional area is preferred.
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