API Technical Lead: Global Transfers & CMO Excellence

RECRUIT EXPRESS PTE LTD; Singapore; On-site; SGD 180,000 - 240,000; Full time

Job summary

RECRUIT EXPRESS PTE LTD in Singapore seeks an API Technical Lead to collaborate with global teams and CMOs on API transfers and supplier qualification.

The role requires managing risk assessments, reviewing quality documentation, and leading improvements in manufacturing processes to meet regulatory standards. A chemistry or chemical engineering background, with an advanced degree, is preferred.

Qualifications

• Bachelor’s degree in chemistry or Chemical Engineering or related scientific discipline.
• Advanced degree preferred with broad post-bachelor's experience in pharma.

Responsibilities

• Act as API Technical Lead with global teams and CMOs.
• Lead API source changes, transfers and supplier qualification.
• Lead complex technical and quality issue resolution at CMOs across chemistry, manufacturing and analytics.
• Provide technical guidance to CMOs and review manufacturing, analytical and technical docs.
• Lead Cost Improvement Projects to reduce API manufacturing costs while maintaining quality.
• Review and approve API specifications, process validation and change controls.
• Conduct risk assessments and FMEA to identify and mitigate technical/manufacturing risks.
• Assess impact of API source/manufacturing changes on chemistry, process robustness and product quality.
• Ensure compliance with quality, regulatory and safety requirements including nitrosamine and GTI assessments.
• Collaborate with internal SMEs, labs, suppliers and stakeholders to ensure project delivery, quality, cost and supply objectives.
• Monitor CMO performance and drive continuous improvement.

Skills

API development

Technology transfer

Supplier qualification

Project management

Risk assessment

Education

Bachelor’s degree in chemistry

Bachelor’s degree in Chemical Engineering

Advanced degree preferred

Job description

RECRUIT EXPRESS PTE LTD in Singapore seeks an API Technical Lead to collaborate with global teams and CMOs on API transfers and supplier qualification.

The role requires managing risk assessments, reviewing quality documentation, and leading improvements in manufacturing processes to meet regulatory standards. A chemistry or chemical engineering background, with an advanced degree, is preferred.