GMP Biologics Manufacturing Specialist

A*STAR - Agency for Science, Technology and Research; Singapore; On-site; SGD 80,000 - 120,000; Full time

Job summary

A*STAR - Agency for Science, Technology and Research is seeking a CMC Specialist with expertise in GMP biologics manufacturing. This role involves directing and supervising the manufacturing of biologics drug products to support clinical development.

Eligible candidates should have an advanced degree in life sciences and 8-10 years of experience in GMP environments, along with strong knowledge of regulatory compliance and CMC requirements. Excellent communication skills and teamwork experience are essential.

Qualifications

• 8–10 years of experience in a GMP manufacturing environment.
• Prior experience in outsourcing and supervising CDMO.
• Experience in authoring and reviewing CMC dossiers for regulatory submission.

Responsibilities

• Direct GMP manufacturing of biologics drug products.
• Ensure compliance with ICH and FDA regulations.
• Collaborate with development teams for timely product delivery.

Skills

GMP manufacturing

Process development

Cross-functional collaboration

Regulatory compliance (ICH, FDA)

Communication skills

Education

Advanced degree in life sciences or related field

Job description

A*STAR - Agency for Science, Technology and Research is seeking a CMC Specialist with expertise in GMP biologics manufacturing. This role involves directing and supervising the manufacturing of biologics drug products to support clinical development.

Eligible candidates should have an advanced degree in life sciences and 8-10 years of experience in GMP environments, along with strong knowledge of regulatory compliance and CMC requirements. Excellent communication skills and teamwork experience are essential.