Global API External Supply Tech Lead (Hybrid)

RECRUIT EXPRESS PTE LTD; Singapore; Hybrid; SGD 102,000 - 122,000; Full time

Benefits offered by this job

Hybrid working arrangement

1.5-month bonus per year

Hybrid working arrangement

APAC travel 10–20%

Job summary

RECRUIT EXPRESS PTE LTD is seeking a Senior Manager – External Supply Technical Lead to steer API external supply projects across the APAC region. You will partner with CMOs and global stakeholders to lead source changes and qualification from technical assessment through implementation.

This senior role covers API chemistry, manufacturing and product quality, driving investigations, risk assessments and technical transfers with a focus on process robustness and change management.

Responsibilities

• Act as the technical lead for API external supply activities, partnering with global Technology & Engineering, Quality, Regulatory, Engineering, CMOs.
• Lead API source changes and alternate CMO qualification from technical assessment through implementation.
• Evaluate source-change impacts from chemistry, manufacturing and product-quality perspectives and drive technical solutions.
• Lead complex CMO investigations involving API chemistry, processing, analytical challenges and product quality.
• Drive cross-functional investigation teams and ensure corrective actions are implemented on schedule.
• Lead technical transfer and process-change activities while assessing manufacturing risks and robustness.
• Develop risk assessments, FMEA and API/DP assessments; support specifications, validation and change-management.
• Provide technical input on supplier performance and identify opportunities for improvement across the external API network.

Job description

RECRUIT EXPRESS PTE LTD is seeking a Senior Manager – External Supply Technical Lead to steer API external supply projects across the APAC region. You will partner with CMOs and global stakeholders to lead source changes and qualification from technical assessment through implementation.

This senior role covers API chemistry, manufacturing and product quality, driving investigations, risk assessments and technical transfers with a focus on process robustness and change management.