Job Description

中国，上海 | 全职 | Job ID: 10566

As subject matter expert (SME) for PK and biomarker bioanalytics, you are responsible for delivering methods and data output for PK, ADA and biomarker analytics required for all phases of clinical trials, each outsourced to external contract laboratories.

Your main responsibilities are:

• Collaborate with PK and translational scientists and relevant R&D teams to lead or provide local support on scientific, technological, strategic, and regulatory guidance, with hands-on contributions to patient selection, biomarker and PK/ADA testing accompanying clinical trials to drive the company’s R&D programs.

• Coordinating PK and biomarker related study activities with internal and external stakeholders and CROs.

• Lead local selection and management of contractors/CROs as appropriate in terms of their technical appropriateness and compliance with the respective regulatory requirements
• Responsibility for method transfer to or method development /validation at external vendors (contract labs)
• Responsibility for oversight of contract laboratories that perform feasibility studies, (further) development, and appropriate analytical validation of methods
• Be familiar with local regulations (e.g., HGR, CDx, biomarker and bioanalytics) to improve biosample management and China strategy with fully compliance.

What you have to offer:

• Degree in chemistry, biology, biochemistry, pharmaceutics or related disciplines
• A minimum of 5+ years of experience in regulated pharmaceutical or regulated biotech industry
• Solid experience in assay development and analytical validation of methods for PK, ADA and biomarker testing or cell based biopotency assays
• In-depth knowledge of GCP/GLP and/or GMP Quality Control as well as FDA, EMA and China requirements
• Ability to express complex issues in concise and clear language, fluency in English (written and spoken)
• Ability to identify problems and find solutions, as well as attention to detail
• Strong cross-functional communication and collaboration skills, and interpersonal agility to navigate complex organizational structures, align priorities, and drive consensus

BioNTech 重视每一位团队成员的福祉，为多元化的员工提供全面的福利保障。我们提供具有市场竞争力的薪酬方案，具体将根据职位、工作地点及候选人资历与经验综合确定。注：各项福利的实际适用范围、享有条件及具体内容可能因所在地而异，最终以公司内部政策及当地法律法规为准。

申请方式： 请通过我们的在线申请链接提交以下材料：

• 个人简历

• 学位证书及职业资格证书复印件

• 联系方式

重要提示：

• 我们仅接受通过链接在线提交的求职申请。

• 提交申请即视为您知悉，招聘流程中将依相关法律法规进行背景调查。如您进入候选名单，BioNTech 将通过合作服务机构“HireRight”开展背景调查工作，招聘专员将及时与您沟通具体安排。

• 我们诚挚期待您的加入。