分析开发经理/Analytical Development Manager 苏州

月薪： 2-2.5万/月

该公司所有职位
  • 5-7年经验
  • 本科
  • 招1人
  • 11-09 发布

职位描述

职位描述： ESSENTIAL RESPONSIBILITIES (Including but not limited to)1.Lead and manage the analytical chemistry team to develop analytical tests for CDMO product.2.Manage the analytical chemistry team to perform the qualification assay supporting PD for CDMO product. Analytical tests includes …..HPLC-SEC, CEX, CE-SDS, Protein A residue, Glycan profiling analysis, peptide mapping3.Communicate and co-work with clients in analytical chemistry part. Explain the data result to client and help to find solution if any questions are found.4.Co-work with PD team to help the protein production. Data analysis: Interpret the result of protein analytical identification and provide the suggestions for PD.5.Technical Review in Technique Transfer to QC (Document and Skill).6.Yearly Goal setting and Performance review in analytical chemistry team.7.Yearly budget setting and reimbursement of analytical chemistry team.8.Communication with supplier to low down the cost.9.The assignment from supervisors.QUALIFICATIONS:1. Specialty: Biology Science, Medicine, Pharmaceutical, Chemistry2. Experience Requirement:3. Bachelor with7~10 years experience or Master with 4~5 years experience in Biologics product industry or Ph.D. with 2~3 years experience in Biologics product industry4. Experience in HPLC-SEC, CEX, CE-SDS, Protein A residue, Glycan profiling analysis, peptide mapping5. Experience in Biologics pharmaceutical industry operation6. Be familiar with Chemistry, Analytical Chemistry, Protein Structure analysis and Medicine field7. Be familiar with the regulation for Biologics Product8. Require English Communication in reading, writing, conversation9. Experience in team leading, project management10. Well communication skill 职能类别： 生物工程/生物制药

联系方式

东平街188号

公司信息

苏桥医药（苏州）有限公司是一家致力于抗体及融合蛋白类生物药物的研发、工艺开发、及中试生产的高科技企业，服务范围全面覆盖临床前研究、临床研究、及商业化生产阶段。总投资额为4,640万美元。 苏桥医药是苏州生物纳米科技园（BioBay）重点扶持的企业之一。苏桥在园区内的建造面积共占地7,000平方米，目标产能1期实现69批次，2期实现92批次。 苏桥将严格遵守国际主流药品监管机构的质量标准，包括CFDA、USA (21-CFR) 、EMA (Eurdralex)、PIC/S以及 WHO。苏桥交付的生产样品能够满足客户在全球多个国家临床试验申请的CMC要求。

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