Senior API MSAT Manager - Cross-Site Tech Transfers

RECRUIT EXPRESS PTE LTD; Singapore; Hybrid; SGD 180,000 - 280,000; Full time

Job summary

RECRUIT EXPRESS PTE LTD seeks a Senior Manager, API MSAT (Contract) to oversee API manufacturing activities with external partners across APAC. This role requires expert API development, tech transfer, and supplier qualification skills, leading multi-site projects and ensuring QA and regulatory compliance.

The role is hybrid in Central Singapore with travel to APAC regions. A strong background in GMP, risk assessment (FMEA) and DMAIC is essential for driving cost improvements and process

Qualifications

• Bachelor’s degree in Chemistry, Chemical Engineering or related field; advanced qualification preferred.
• Extensive API development, manufacturing or technical operations experience in pharma.
• Deep knowledge of API manufacturing, technology transfer, and the impact of process and source changes.
• Experience qualifying new API suppliers and managing source-change projects.
• Experience working with Contract Manufacturing Organisations (CMOs).
• SME-level knowledge in API development, process qualification, process validation and API manufacturing.
• Strong understanding of GMP, quality systems and regulatory change requirements.
• Experience applying risk management tools (FMEA) and DMAIC methodologies.

Responsibilities

• Act as the technical lead for externally manufactured APIs and represent the technical function within cross-functional teams.
• Lead API source-change activities, technical transfers and qualification of alternate CMO suppliers.
• Build and lead cross-functional project teams, manage implementation plans and communicate status, risks and milestones.
• Lead complex technical and quality investigations at CMOs involving chemistry, process, analytical or product-quality issues.
• Review CMO technical documentation, including manufacturing data, analytical results and specifications.
• Provide technical guidance to CMOs and support resolution of manufacturing, quality and compliance challenges.
• Lead Cost Improvement Projects to reduce API manufacturing costs and improve performance.
• Provide technical review and approval for change-management activities and process validation.

Skills

API development

Technology transfer

Project leadership

Supplier qualification

Cross-functional collaboration

GMP knowledge

FMEA

DMAIC

Regulatory change management

Stakeholder management

Education

Bachelor's in Chemistry/ Chemical Engineering

Tools

Minitab

QMS

Job description

RECRUIT EXPRESS PTE LTD seeks a Senior Manager, API MSAT (Contract) to oversee API manufacturing activities with external partners across APAC. This role requires expert API development, tech transfer, and supplier qualification skills, leading multi-site projects and ensuring QA and regulatory compliance.

The role is hybrid in Central Singapore with travel to APAC regions. A strong background in GMP, risk assessment (FMEA) and DMAIC is essential for driving cost improvements and process