QC物料高级工程师

BioNTech • Chinese: C1 • Biotechnology • Health Care • Microsoft Excel • 27 days ago

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Location

In office (Nantong)

Seniority

Senior

Confirmed on the employer's own hiring board on Oct 19, 2026. First seen by Alion on Sep 23, 2026.

Overview

Company

Impact

Profile match

BioNTech

BioNTech is a German biotechnology company founded in Mainz in 2008 by the physician-scientists Ugur Sahin and Ozlem Tureci to develop individualised cancer immunotherapies using messenger RNA. Its mRNA platform, refined over a decade on oncology programmes, was redirected in early 2020 to produce Comirnaty with Pfizer, the first COVID-19 vaccine authorised in the West and the source of tens of billions of euros in revenue. The company has reinvested that windfall into its original mission, running a broad clinical pipeline of mRNA cancer vaccines, individualised neoantigen therapies and bispecific antibodies including the closely watched BNT327 programme.

biontech.com • HQ: Mainz, Germany • Vaccines • Cell & Gene Therapy • Infectious Disease Therapeutics • Oncology Therapeutics • Prescription Drugs • 5000+ employees • Est. 2008

Tech stack of BioNTech

岗位职责：

负责QC实验室原辅料与包装材料的检验及相关工作;
负责原辅料及药包材的质量标准的建立、维护与更新;
负责原辅料及药包材的检验规程的建立、维护与更新; 负责检测方法的确认或验证;
负责原辅料检验用分析仪器的引入与确认;
负责执行原辅料与药包材的取样与检验;
负责原辅料及药包材第三方实验室的确认与管理，以及第三方实验室委托检验的管理;
负责原辅料检验过程中偏差及OOS的调查、以及变更的处理。
与QC内部理化、生化、微生物、运营等组密切协作，确保样品检测及时、准确;
完成上级领导交付的其他工作。

任职要求：

至少7年及以上原辅包的检测经验，有生物制品行业相关经历的，优先考虑;
掌握多种物料检测方法能力，如化学鉴别、含量和杂质等; 掌握相应检测设备的工作原理，如IR、UV、HPLC、GC等;
熟悉中国药典、GMP指南，及ICH等关于原辅料管理的法规和指南等; 了解EP、USP等国外药典关于物料管理;
能在GMP环境中独立执行分析工作，并最大限度地减少实验室误差;
英语看说写熟练;
具备良好的职业素养和团队协助能力;
熟练使用 MS-Word, MS-Excel, MS-Outlook等办公软件。

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