(Pharma MNC) 2 Years Contract Pharma API Technical Senior Manager (Manage 3rd Party Pharma Manufacturer) (Up 11K) #HJC

• Act as the API Technical Lead, working with global teams and external Contract Manufacturing Organisations (CMOs).
• Lead API source changes, technical transfers and qualification of alternative suppliers, including planning, coordination and project management.
• Lead and resolve complex technical and quality issues at CMOs, covering chemistry, manufacturing and analytical processes.
• Provide technical expertise and guidance to CMOs and review manufacturing, analytical and technical documents.
• Lead Cost Improvement Projects (CIPs) to reduce API manufacturing costs while maintaining product quality and performance.
• Review and approve technical and quality documentation, including API specifications, process validation and change controls.
• Conduct risk assessments, FMEA and process evaluations to identify potential technical and manufacturing risks and develop mitigation plans.
• Assess the impact of API source/manufacturing changes, including chemistry, process robustness and product quality.
• Ensure compliance with relevant quality, regulatory and safety requirements, including nitrosamine and GTI assessments.
• Work closely with internal SMEs, laboratories, suppliers and global stakeholders to ensure successful project delivery, quality, cost and supply objectives.
• Monitor CMO performance and supplier relationships, providing technical feedback and driving continuous improvement.

Education, Background and Experience

• Bachelor’s degree in chemistry, Chemical Engineering, or a related scientific discipline. An advanced degree is preferred, with broad post-bachelor's experience relevant to the pharmaceutical industry.
• Broad knowledge of technology transfer processes and manufacturing of Active Pharmaceutical Ingredients (APIs), together with a strong technical understanding of pharmaceutical processes and the impact of technical change.
• Demonstrated experience and competence in organising, planning, and problem-solving related to qualifying new API suppliers.
• Demonstrated ability to build constructive working relationships within multifunctional teams supporting projects, as well as positive relationships with CMOs.
• Ability to prioritise activities effectively.
• Knowledge of filing process documentation requirements, quality systems, and manufacturing operations.
• SME in API development, process qualification, source change qualification, and API manufacturing. Broad knowledge of technology transfer processes and manufacturing of Active Pharmaceutical Ingredients, together with a strong technical understanding of pharmaceutical processes and the impact of technical change.

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TELE me at @jacechooo or WA me at https://wa.me/+6582976283 NOW!

Interested candidates please submit your resume to [email protected]

Jace Choo Oi Kei

Personnel EA License No.: R1875164

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