About the role
AI summarisedCMC Project Manager role at Hummingbird Bioscience in Singapore, Singapore.
BiotechOnsiteCMC Project Management
Key Responsibilities
- (but are not limited to): Provide project management for Chemistry, Manufacturing and Control elements for Hummingbird Bio’s pipeline programs which are in clinical studies or are in pre-clinical development.
- Management of contract development and manufacturing organizations (CDMOs) for clinical supply from Drug Substance, Drug Product and Final Packaging.
- Where required, management of the supply chain for combination trials.
- Serve as a point of contact for various stakeholders, including, Regulatory CMC, Quality Assurance, Process Development, Analytical Development when advancing the CMC program through clinical development.
Requirements
- BSc.or BEng.
- Biotechnology, Pharmaceutical Sciences, Chemical Engineering or related Biological Sciences Broad familiarity with the drug development process with at least 5 years of relevant experience in process/analytical development or clinical manufacturing Ideally with 2 years of experience in project management for manufacturing, CMC, Process/Analytical Development for Biologics A working knowledge or previous experience, either in the industry or as part of the educational training of process/analytical development and manufacturing for antibodies or other biologics.
- Excellent organizational, communication [both oral and written], and interpersonal skills.
- Systematic and detail orientated organizing complex plans and addressing issues and risks.