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.
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
Advanced degree in Analytical Chemistry, Medicinal Chemistry, Antibody Engineering
Building 12, No. 260 Sixth Street, HEDA, Hangzhou City, Zhejiang Province, CHINA
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