Responsible for the technology transfer of antibody and conjugation projects. Write and complete technology transfer documents according to the project timeline, including but not limited to Facility/Process Fit, GARA, BOM, PFD, SPL, MBR, technology transfer reports, and campaign summary reports. Support new product introduction evaluation and ensure timely communication on the status of project technology transfer.
Design and implement process validation protocols for antibody and conjugation projects. Write and approve validation reports while providing necessary on-site production support.
Oversee and track the readiness of materials and equipment for GMP production.
Support ongoing qualification, periodic review, and revalidation of commercial manufacturing projects in the plant.
Manage internal and external communication related to the project. Keep clients and the CMC team updated on project progress and coordinate discussions on process and technical topics with clients.
Write IND/BLA dossiers related to drug substrate (DS) manufacturing.
Support or lead client audits and official inspections, and assist clients with Person-in-plant (PIP).
Requirements
Bachelor’s degree or higher in life sciences or engineering, such as chemical engineering, bio-engineering, biology, or pharmaceutical science.
Priority will be given to candidates with at least 3 years of relevant tech transfer experience in the production of large molecule drugs or conjugated drugs.
Strong communication, teamwork, logical thinking, and execution skills, with the ability to work under pressure.
Familiarity with GMP requirements and documentation practices
Excellent English proficiency in reading, writing, and speaking, with strong meeting organization and document writing skills, bilingual ability (e.g., Chinese, Japanese, Korean) is a plus but not compulsory.
