Lead - Technology Transfer (API Plant)

Leadership & Team Management

• Lead, mentor and build the technology transfer team (scientists, process engineers, officers) for the API plant.
• Define roles, allocate projects, review performance, and drive capability building / technical training within the team.
• Act as the single point of accountability for all tech transfer projects at the site, coordinating across R&D, QA, QC, Production, Engineering, EHS and Regulatory Affairs.

End-to-End Technology Transfer

• Own the tech transfer process from R&D handover through pilot / engineering batches, exhibit / validation batches, to sustained commercial production.
• Review and approve Technology Transfer Documents (TTD), risk assessments, Master Batch Records (MBR/BMR), and process flow diagrams prior to plant execution.
• Identify Critical Process Parameters (CPPs), Critical Quality Attributes (CQAs), and Critical Material Attributes (CMAs) in collaboration with R&D and QA; drive process risk assessments (FMEA).
• Plan and oversee scale-up trials, resolve scale-dependent deviations in yield, purity, impurity profile, and process safety.
• Assess plant / equipment fitment (reactor capacity, materials of construction, utilities, containment) for new product introduction and recommend engineering modifications.

Quality, Compliance & Regulatory Support

• Ensure all tech transfer activities comply with cGMP and applicable regulatory guidelines (USFDA, EU-GMP, WHO-GMP, ICH Q8/Q9/Q10/Q11, as applicable).
• Review and approve process validation protocols and reports; ensure validation batches meet predefined acceptance criteria.
• Support customer and regulatory audits (USFDA, EU, WHO, customer QA) on technology transfer and process documentation.

Process & Cost Optimization

• Drive yield improvement, cycle-time reduction, solvent recovery, and cost optimization initiatives during and after tech transfer.
• Champion Quality by Design (QbD) and continuous improvement / Kaizen initiatives across transferred processes.