Drug Substance MSAT Engineer

WUXI XDC SINGAPORE PRIVATE LIMITED; Singapore; On-site; SGD 120,000 - 180,000; Full time

Job summary

WUXI XDC SINGAPORE PRIVATE LIMITED is seeking a qualified professional to lead technology transfer for antibody and conjugation projects in Singapore. You will design and implement process validation protocols and ensure timely communication on project status to clients and the CMC team.

The role requires a Bachelor's degree in life sciences or engineering, at least 3 years of tech transfer experience with large molecule or conjugated drugs, and excellent English, documentation and teamwork

Qualifications

• Bachelor's degree in life sciences or engineering.
• At least 3 years of tech transfer experience for large molecule or conjugated drugs.
• Excellent English (reading, writing, speaking) with strong documentation skills.
• Bilingual ability (e.g., Chinese, Japanese, Korean) is a plus.

Responsibilities

• Write and compile technology transfer documents per project timeline (F/PFD, MBR, product reports).
• Design and implement process validation protocols for antibody/conjugation projects.
• Prepare and approve validation reports and provide on-site production support.
• Coordinate internal/external communications and update clients and CMC team on progress.
• Support client audits and inspections; assist with Person-in-plant (PIP).
• Oversee material/equipment readiness for GMP production.

Skills

Communication

Teamwork

Logical thinking

Execution

GMP knowledge

Documentation

Education

Bachelor's degree in life sciences or engineering

Job description

About the role

Responsible for the technology transfer of antibody and conjugation projects. 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. Manage internal and external communication related to the project.

Key responsibilities

• Write and complete technology transfer documents according to the project timeline, including Facility/Process Fit, GARA, BOM, PFD, SPL, MBR, technology transfer reports, and campaign summary reports
• 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 and keep clients and the CMC team updated on project progress
• 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)

About you

• Bachelor's degree or higher in life sciences or engineering, such as chemical engineering, bio-engineering, biology, or pharmaceutical science
• 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