武汉招聘

Principal Duties and Responsibilities

 岗位职责

• Participate in protein physicochemical analysis（including purity testing（by HPLC,CE）, concentration testing，etc）and biochemical analysis（including Residual HCP,HCDNA,ProteinA testing,etc）

      参与蛋白理化分析（包括用HPLC,CE进行纯度检测，浓度检测等）和生化分析（包括残留HCP,HCDNA,Protein A 等）

• Participate in analytical method development, qualification,validation and method transfer of physicochemical and biochemical testing.

      参与理化和生化检测的分析方法开发，确认，验证和方法转移。

• Perform routine analysis of MSAT as well as GMP samples, including in-process according to SOPs.

       根据SOP执行MSAT 和GMP 样品的常规分析，包括中控样品等。

• Provide analytical technical support to MSAT cell culture group and purification group in process development trouble shooting, tech transfer and scale-up activities.

       对MSAT 细胞培养组和下游纯化组的工艺开发问题解决，技术转移及放大提供分析技术支持。

• Perform analytical data analysis ，data review and trending analysis .

       负责数据分析，数据审核和趋势分析。

• Perform technical writing assignments such as SOPs, protocols, reports,  risk assessments, laboratory investigations, etc.

       负责起草技术文件包括操作规程，草案，报告，风险评估，实验室调查报告等。

• Write and review IND, BLA and other regulatory documents.

       撰写和审核IND,BLA和其他法规文件。

 

Job Requirements

岗位要求

• Bachelor’s degree in chemistry, biochemistry, biology or related disciplines , analytical experience in biotech pharmaceutical industry is prefered,

       化学，生化，生物学或相关专业的学士，有生物制药行业的分析相关工作经验会优先考虑。

• Experience developing bioassays and biophysical potency assays; familiar with method validation

       熟悉方法验证，有生物效能开发与分析经验。

• Strong background in understanding of methodologies for biologics products

       对生物产品方法学背景有一个较强的理解。

• Be familiar with equipment using of protein analysis，such as HPLC,CE,iCE3,UV spectrometer,microplate reader,Q-PCR equipment.

       熟悉如下仪器进行蛋白分析，包括HPLC,CE,iCE3,UV分光仪,酶标仪，Q-PCR仪等。

• Be familiar with analytical method development,qualification,validation and method transfer of physicochemical and biochemical assays.

       熟悉理化和生化分析的方法开发，确认，验证和转移过程。

• Understand ICH，ChP regulations and guidelines.

      了解ICH, ChP法规和指导原则。

• Excellent oral and written communication skills in English.

       有良好的英文口语和书面沟通能力。

鼎康生物是一家领先的CDMO公司，可提供一站式的CMC解决方案，支持从早期药物开发到后期临床研究和商业化cGMP生产。鼎康引进了全球***模块化生物制药工厂Kubio；为客户开发的多个产品已经在全球20多个国家进行临床试验。在不久的将来，鼎康生物总产能将超过140,000L。我们承诺通过技术和生产创新，使全球患者都能负担得起具有国际标准的生物药物，提高治疗水平以改善人类健康。