Drug Substance MSAT Engineer

WuXi XDC; Singapore; On-site; SGD 100,000 - 160,000; Full time

Job summary

WuXi XDC is seeking a qualified technology transfer specialist to manage antibody and conjugation project transfers, document preparation, and validation activities in a fast-paced GMP environment.

You will write and review transfer dossiers, ensure readiness of materials and equipment for GMP production, and maintain proactive communication with clients and the CMC team throughout the project lifecycle.

Qualifications

• Bachelor's degree or higher in life sciences or engineering.
• At least 3 years of tech transfer experience in production of large molecule drugs or conjugated drugs.
• Excellent English reading, writing and speaking with strong meeting organization and document writing skills.
• Familiarity with GMP requirements and documentation practices.

Responsibilities

• Lead technology transfer documentation according to project timeline (Facility/Process Fit, GARA, BOM, PFD, SPL, MBR, tech transfer reports, campaign summaries).
• Design and implement process validation protocols for antibody and conjugation projects; write validation reports and provide on-site production support.
• Oversee readiness of materials and equipment for GMP production.
• Support qualification, periodic review, and revalidation of commercial manufacturing projects.
• Coordinate with clients and CMC team on process and technical topics; manage communications.
• Write IND/BLA dossiers related to drug substrate manufacturing.
• Assist client audits and inspections and support Person-in-plant engagements.

Skills

Communication

Teamwork

Logical thinking

Execution skills

English proficiency

Education

Bachelor's degree in life sciences or engineering

Job description

• 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