(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 jacechoo@recruitexpress.com.sg

Jace Choo Oi Kei

Personnel EA License No.: R1875164

Recruit Express Pte Ltd (EA Licence No.: 99C4599)

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