About the position
We are seeking a highly skilled Manufacturing Technology Specialist / Manager to provide technical and scientific support for technology transfer, process optimization, and cost-efficiency initiatives across Contract Manufacturing Organizations (CMOs).
The role will drive alternative vendor development for APIs, IPIs, and packaging, support troubleshooting and deviations, and ensure regulatory compliance while collaborating closely with internal teams and CMOs to improve processes and productivity.
Key Responsibilities:
Technology Transfer & Validation
• Develop, review, and implement technology transfer protocols (PQ, PPQ, CPV, scale-up/assessment batches).
• Conduct gap assessments at receiving CMOs (facilities, utilities, equipment).
• Compile technical data packages, product transfer documentation, and ensure regulatory requirements are met.
• Lead and monitor technology transfer activities at CMOs, ensuring adherence to timelines.
• Provide technical guidance during trial, engineering, and validation batches; optimize process parameters.
• Review batch execution records, validation reports, and close change controls in compliance with SOPs.
Process Optimization & Cost Efficiency
• Evaluate batch sizes, yields, and cycle times; recommend improvements to reduce cost and increase throughput.
• Lead alternative vendor development projects for APIs, IPIs, and packaging.
• Perform root-cause analyses for yield losses and inefficiencies at CMOs.
• Support scale-up, revalidation, and line improvements to enhance productivity.
Technical Issue Resolution
• Investigate and resolve deviations, OOS, OOT, FMECA, and customer complaints.
• Collaborate with Quality, Product Development, and CMO technical teams to implement CAPAs.
• Provide scientific guidance to CMOs during troubleshooting.
Regulatory & Documentation Support
• Prepare technical documents for regulatory submissions.
• Ensure compliance with cGMP and international regulatory standards (FDA, EMA, WHO, SAHPRA, etc.).
• Maintain audit-ready technical files and documentation.
Continuous Improvement
• Identify opportunities for process simplification, automation, and data-driven decision-making.
• Promote standardized transfer methods and cross-site process excellence.
• Conduct techno-commercial audits during CMO visits and implement improvement actions.
Requirements / Skills:
• Bachelor’s degree in Mechanical Engineering, BPharm, Industrial Engineering, Chemical Engineering, or related field.
• 5–10 years’ experience in pharmaceutical manufacturing, including tech transfer, validation, and automated manufacturing/packaging lines.
• Strong knowledge of technology transfer, process validation, troubleshooting, deviation management, and regulatory compliance (cGMP).
• Experience in alternative vendor development, process optimization, or CMO technical management preferred.
• Excellent technical writing, communication, leadership, planning, and project management skills.
• Proficiency in SAP and Microsoft Office.
• Knowledge of multiple dosage forms is advantageous.
Desired Skills:
- Manufacturing Technology Specialist
- Manufacturing Technology Specialist
- Manufacturing Technology Specialist
