Drug Substance MSAT Engineer

Key Responsibilities

• 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.