Company introduction: NeoLogics Bioscience Co., Ltd was founded in Suzhou, 2018. Currently it is a pre-clinical stage biotech company focusing on biologics for immune modulation. The disease areas cover cancer, autoimmune and inflammation.
Our company is committed to lead the innovation of truly BIC (best in class) and FIC (first in class) biological immunotherapies for the benefit of patients worldwide. We have integrated robust in silico data mining, analyzing and phenotypical target validation system to ensure a sustainable pipeline. We also leverage resources from mature CRO, CDMO in China to advance our pipeline to certain milestones.
For the present, we have two drug candidates in IND enabling stage and 5 candidates in early discovery stage. We have just secured 15Mn $ pre-A round financing and are looking for talents to join us.
Job Description:
- CDMO evaluation and management. Responsible for the overall management of the Biopharmaceutical CMC site, including managing project progress, communicating and formulating R&D plans, department budgets and daily management.
- Manage interactions with FDA and other global regulatory authorities for assigned project(s) to ensure acceptance, rapid review and approval of marketing.
- Responsible for the upstream and downstream of the CMC sector, taking over new drug molecule to conduct process evaluation, PD process development, pilot production, process and analysis method transfer, clinical sample production, and IND application.
- Serve as the regulatory CMC representative on project teams. Provides CMC regulatory support and guidance for assigned projects and interfaces with R&D, Project Management, Manufacturing, Quality, and Regulatory colleagues, as well as third party laboratories, global collaborations partners and contract manufacturers. Monitor integrated biologics early CMC plans including milestone, timeline and resources.
- Guide and Help CRO for tech questions, batch release, risk evaluation et.
Qualification
- Master-Ph.D. degree in biotechnology, bioengineering and related fields.
- Experience in cell line screening, process development (upstream cell culture, downstream purification), optimization, characterization and other macromolecular project development.
- Over 3 years CMC biologics working experience in Pharma or Biotech, covering PCC-IND whole process for biologics candidates. 5 years CMC biologics working experiences is required if candidate is a Master Degree.
- Has excellent scientific research capabilities and accomplishments, and have strong interest in scientific research.
- Has clear scientific research methods and strong ability to analyze and solve technical problems.
- 6.Has excellent capabilities in team management.
- Excellent verbal and written communication skills in both English and Chinese is a plus.
- Posssible domestic or international travel. This position will be located in suzhou, China.
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