Senior Manager, API MSAT (Pharmaceutical MNC) HMZ

Recruit Express Pte Ltd; Singapore; Hybrid; SGD 180,000 - 240,000; Full time

Job summary

Recruit Express Pte Ltd is seeking a Senior Manager, API MSAT to oversee external API manufacturing activities across CMOs, ensuring robust technology transfer, qualification and process validation across APAC sites. Central location with hybrid work and light travel to APAC regions.

You will lead cross-functional teams, manage complex transfers, review technical documentation, drive cost improvements and ensure GMP compliance, with hybrid work in Central Singapore and travel as needed.

Qualifications

• Bachelor’s degree in Chemistry or Chemical Engineering; advanced qualification preferred.
• Extensive API development, manufacturing or operations experience.
• Experience with CMOs and API supplier qualification.
• Strong knowledge of GMP, validation and regulatory change.
• Familiarity with risk-management tools such as FMEA and DMAIC.

Responsibilities

• Act as the technical lead for externally manufactured APIs and represent the technical function within cross-functional supply and operations teams.
• Lead API source-change activities, technical transfers and qualification of alternate CMO suppliers.
• Build and lead cross-functional project teams, manage implementation plans, track actions and communicate project 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, operating instructions, specifications and technical reports.
• 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 product and process performance.
• Provide technical review and approval for change-management activities, API specifications, process validation and related technical assessments.
• Assess API process robustness, source-change impact and material-property risks, and develop appropriate mitigation strategies.
• Conduct technical risk assessments, FMEAs and API / Drug Product interface assessments for process changes and transfers.
• Coordinate with internal SMEs, development teams and support functions to resolve technical issues and deliver project objectives.
• Monitor supplier technical performance and provide feedback to support effective external manufacturing partnerships.

Skills

API development

Technology transfer

Process validation

CMC knowledge

GMP/regulatory

Education

Bachelor's Degree in Chemistry or Chemical Engineering

Advanced qualification preferred (MSc/PhD)

Job description

Senior Manager, API MSAT

An established global pharmaceutical organisation is seeking a senior technical leader to oversee Active Pharmaceutical Ingredient (API) manufacturing activities across external manufacturing partners. This role is suited to an experienced API SME with strong technical transfer, supplier qualification, process validation and CMO management experience who can lead complex cross-functional projects across multiple sites and geographies.

Work Location: Central; Hybrid

Travel: Some light travel requirements to APAC regions

Employment: Permanent

Job Responsibilities

• Act as the technical lead for externally manufactured APIs and represent the technical function within cross-functional supply and operations teams.
• Lead API source-change activities, technical transfers and qualification of alternate CMO suppliers.
• Build and lead cross-functional project teams, manage implementation plans, track actions and communicate project 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, operating instructions, specifications and technical reports.
• 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 product and process performance.
• Provide technical review and approval for change-management activities, API specifications, process validation and related technical assessments.
• Assess API process robustness, source-change impact and material-property risks, and develop appropriate mitigation strategies.
• Conduct technical risk assessments, FMEAs and API / Drug Product interface assessments for process changes and transfers.
• Coordinate with internal SMEs, development teams and support functions to resolve technical issues and deliver project objectives.
• Monitor supplier technical performance and provide feedback to support effective external manufacturing partnerships.

Who Should Apply

• Experienced API technical leaders with strong exposure to API development, manufacturing, technology transfer, process validation and source-change qualification.
• Candidates who have worked extensively with CMOs and are comfortable leading complex cross-functional technical projects across multiple sites.
• Senior pharmaceutical professionals who combine deep chemistry / chemical engineering expertise with strong stakeholder management, problem-solving and project leadership skills.

Requirements

• Min. Bachelor’s Degree in Chemistry, Chemical Engineering or a related scientific discipline; advanced qualification preferred.
• Strong post-degree experience within pharmaceutical API development, manufacturing or technical operations.
• Deep knowledge of API manufacturing, technology transfer and the impact of process and source changes.
• Demonstrated experience qualifying new API suppliers and managing source-change projects.
• Strong experience working with Contract Manufacturing Organisations.
• SME-level knowledge in API development, process qualification, process validation and API manufacturing.
• Strong understanding of pharmaceutical quality systems, GMP, validation and regulatory change requirements.
• Experience reviewing technical manufacturing documentation, specifications and analytical / process data.
• Good knowledge of risk-management tools, including FMEA and technical risk assessments.
• Experience applying Operational Excellence tools such as DMAIC.
• Strong project-management, communication and stakeholder-management skills.
• Able to work independently across multiple projects, sites and functions.
• Knowledge of Drug Product processes, Process Safety, EHS, digital technologies or data analytics will be advantageous.