GMP Plasmid Production Process Developer

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刷新于 2 年前
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工作职责
GMP Plasmid Production Process DeveloperCOMPANY OVERVIEWShanghai JW Biological Products is a new biotechnology company based in ZhangJiang Cell therapy park- Shanghai, China. The company is specialized in High Quality,small-scale plasmid production. The company started in July 2020, and is right nowcomposed of six employees and still expanding.Plasmids are considered as the most critical raw materials in the production of severalgenetically modified therapies. JW’s goal is to develop customized plasmid productsto meet the requirements of an increasingly demanding healthcare. We are looking tomove forward and produce GMP grade plasmids for personalized medicine.JW BP is looking for a GMP Plasmid Production Process Developer.Responsibilities:His/her main missions will be:- identify best process to set-up, based on literature and preliminary tests- work with IP- implement scale-up strategy- select appropriate equipment for the selected strategy- set-up and validate whole process- deliver SOPs and any documentation required to meet GMP requirements- transfer the process to the GMP manufacturing unitBest regardsDavid
职位要求
Responsibilities and Qualifications:We expect him/her to have:- >3 years in biomedical-related industry- Experience in process development, with special emphasis on technologychoice, process validation.- Awareness of GMP regulations, gene and cell therapy, injectable productregulations- Expertise in middle scale plasmid production, both USP and DSP: bacterialfermentation, chromatography, TFF filtration- Good English communication skills, Chinese would be a bestSalary and Other Benefits:- Gross Salary before taxes: depends on experience and competencies- Allowance for leasing apartment- Medical Insurance to cover China and travel allowance.
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