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  • Director or Associate Director in QC Department
    Job Description


    Hangzhou DAC Biotech Co., Ltd is a research-based biopharmaceutical company formed in 2012 by a group of senior principal scientists from US based biopharma companies. Hangzhou City is one of the most beautiful cities in China, called “One of Two Paradise Places” on earth by Chinese since ancient time (more than 800 years now). Hangzhou DAC Biotech Co., Ltd combines the focus and passion of a leading-edge biotech with the expertise and capabilities in ADC field to develop and market advanced therapies that address some of the world's most complex and serious diseases of cancer.

     

    The CMC team within Hangzhou DAC Biotech develops phase appropriate drug products for small molecule, mAb and antibody drug conjugate (ADC) programs, supporting pre-clinical studies through commercial registrations. We prepare GMP drug products to develop the company pipeline, and ultimately we provide commercial manufacturing processes for product launches.

      

    Hangzhou DAC Biotech Co., Ltd is seeking a highly motivated individual with a proven track record of leadership to serve as Director or Associate Director in QC Department. This individual will have strong collaborations within CMC, as well as with other R&D and Commercial Manufacturing Operations functions. Successful candidate will have an extensive expertise in development activities associated with drug substance and drug product process development and scale up. They will have the ability to develop and communicate a clear and concise business strategy, demonstrate effective decision making, and manage and inspire their team to thrive in a dynamic environment with a specific emphasis on analytical method development and control strategies.

     

    Primary Job Function


    Lead and manage analytical teams that conduct analytical research in R$D through commercial registration with high scientific rigor and implementation of analytical process control strategies to advance small molecule drug discovery candidates


    Work collaboratively with other functional areas outside Analytical to advance projects through the pipeline.


    Support new product development with advanced method development and validations, technical transfer packages, and generation of technical data in support of clinical compounds and drug product regulatory requirements.


    Ensure the development of strategies that drive scientific excellence and innovations that improve the future capabilities and productivity of the greater organization.


    Responsible for leadership and technical development within the function generating future leadership for the function. This includes establishing a sustainable high functioning team, managing performance of the team and in conjunction with team members, developing career paths for growth.


    Form strong cross-functional alliances across R&D and Commercial Manufacturing Operations to ensure robust and effective process development control strategies with efficient analytical technical transfer


    Assures compliance with the company safety, quality and regulatory policies and government regulations


    Level and compensation will be commensurate with experience.


    Basic:


    Bachelors, Masters, or PhD in Analytical Chemistry with a minimum of 10 (BS), 6 (MS), or 4 (Ph.D) years related industry experience


    Strong technical background in analytical chemistry


    Demonstrated leadership of technical teams and effective cross-functional communication


    Demonstrated capability to solve critical scientific and business problems.


    Demonstrated ability to implement and to grow capabilities of an analytical organization and develop people into future leaders


    Extensive QC experience in drug substance and drug product process development, scale-up from pilot plant to a commercial facility, and analytical tech transfer to partner’s laboratories


    Understanding of cGMP and regulatory requirements


    Builds strong relationships with peers and cross functionally with partners outside of team to enable higher performance


    Preferred:

    Advanced degree in Analytical Chemistry, Medicinal Chemistry, Antibody Engineering


    Address:

    Building 12, No. 260 Sixth Street, HEDA, Hangzhou City, Zhejiang Province, CHINA

    Tel: 86-571-5605-0590

    Email: info@dacbiotech.com




  • 药物分析工程师

    岗位描述

    1. 根据公司发展战略规划,进行新药研发项目的立项并有效推进方案;

    2. 带领创新药物研发团队发现并设计先导化合物和有效的实施;

    3. 设计和优化合理的药物合成和纯化工艺路线,以及cGMP放大实施方案;

    4. 撰写新药注册申报所需的技术资料;对项目的实施严格地实行质量控制(包括各种文字和材料的记录、修改和实验安全的管控等)

    5. 管理好所带领的研发团队,激发创新潜能,并进行高团队绩效评估。 6. 定期提交项目进展报告

    岗位要求

    1. 药物化学,有机化学或相关专业博士,毕业后从药物化学研发3年以上(含博士后经验)的优先。

    2. 在小分子药物研发方面具有扎实的专业理论基础和出色的动手能力,工作积极主动,能独立完成高水平的实验工作。

    3. 具有创新思维和独立发现、分析、解决问题的能力。海外工作背景(含博士后背景优先考虑)。

    4. 掌握一定的领导艺术,能够有效地指导团队成员的工作。

    5. 具有高度的责任心和团队协作精神,遵守公司的规章制度。 

    6. 精通英语和中文。

  • 制剂生产技术员



    岗位描述



    1. 参与设备操作及生产岗位SOP文件起草


    2. 按照SOP熟练操作各种生产设备进行GMP生产


    3. 参与工艺设备的安装、调试、测试、验证等工作


    4. 操作关键设备包括:冻干机、灌装机、灭菌柜、轧盖机等


    5. 参与平时制剂岗位的溶液过滤及配制等


    6. 关注制剂工艺和工艺相关设备的状态,针对问题,提出改进方案并实施


    7. 对设备运行过程中发生的问题,能及时总结原因,找出措施及提出防范方法


    8. 遵守EHS和GMP的其他有关规定

    岗位要求:


    1.药学类或相关专业大专以上学历,三年以上药厂工作经验,熟悉冻干制剂的生产过程


    2.绝对服从上级领导分配的工作任务


    3.具有较强组织管理协调能力和分析解决问题能力


    4.吃苦耐劳,勤奋学习具有较强的责任心及较好的团队合作精神


    5.处女座优先