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Process Development and Manufacturing Scientist Nr ref.: /JOBS.pl Proclinical is searching for a Process Development and Manufacturing Scientist on behalf of our client - a growing biotech based in Singapore. They specialize in the research, development and commercialization of cancer immunotherapy treatments. Job Description Hands-on bench scientist who can work independently on isolation, culture (tissue culture vessels, bags, bioreactors), and characterization of cells under Good Manufacturing Practice(cGMP)-compliant cell manufacturing facilityIdentify and design technical and methodological solutions to a wide range of complex manufacturing issues based on extensive knowledge of biotechnology and bio manufacturingCells populations typically include T cells, dendritic cells and derivatives thereof intended for infusionParticipate in all aspects of process development, transition to GMP-compliant use, regulatory compliance and FDA IND proposal writingDevelop standard operating procedures, batch records and product specifications documentation in compliance to cGMP guidelinesWork closely with research scientists, process engineers and quality personnel to improve process work flow and operational efficiencyDevise integrated scale-up and scale-out processes to transfer technology from the research to manufacturingCoordination of multiple projects, both in Process Development phase as well as in GMP manufacturingDeveloping, reporting and managing work packages for core teams to meet project timelinesProactively find and supervise (solutions to) bottle necks, deviations, risks and changes which could lead to planning conflicts or cost changesPositive collaboration with internal departments participating in projectsTrain skilled technical professionals and facilitate setup of satellite laboratories overseas Requirements: Bachelor Degree in Bioengineering/Life Sciences or any related field with at least 4 years of manufacturing experience in biopharma/biologics or any relevant industryComprehensive knowledge of the principles of cellular immunology, biological process engineering and cellular therapiesExperience in culturing and expansion of human immune cells is a mustExperience in cellular bioreactor will be an added advantageGood understanding of principles of cGMP, FDA compliance, raw materials and documentation requirementsTravelling is a must and willingness to have a flexible schedule when neededExcellent organizational and problem solving skillsExcellent presentation and writing skills, with experience reporting to management team is a plusStrong project management and leadership skillsGood interpersonal and communications skills To Apply:Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable. A full job description is available on request.ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies. Kontakt: Aplikuj teraz Ogłoszenie pochodzi z serwisu Jobs.pl .

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