Senior Manager, API MSAT (Contract)
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
Contract Duration: 2 Year Contract (With potential extension or conversion depending on project requirements and individual performance)
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.
Qualified applicants, please email your detailed CV to:
[Confidential Information]
All information will be treated with confidentiality and we regret that only selected candidates will be notified
Consultant: Melanie Tay (Zheng Zhiyuan)
Designation: Division Manager
CEI Reg No: R1104774
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