Job Description

Operation, Maintenace and troubleshooting of BFS machine Lead Technology Transfer activities from FRD to internal and external (CMO) manufacturing sites for sterile dosage forms. Drive CMO selection based on technical capabilities, capacity, regulatory compliance, and project feasibility. Plan and execute site readiness, including audit preparation, gap assessment, and technical capability mapping. Review and finalize regulatory submission documents (Module 3 - CMC) and provide timely responses to agency queries in coordination with Regulatory Affairs. Define and oversee batch execution strategy, including scale-up, exhibit, and validation batches. Monitor and guide the preparation and review of key documents including BMRs, validation protocols, and technical reports. Coordinate with cross-functional stakeholders -Project Management, R&D, QA, QC, Regulatory, SCM, and Manufacturing - for seamless knowledge transfer and project execution. Act as a single point of contact for technical discussions with internal teams and CMOs. Identify and resolve process challenges during scale-up and commercial execution, ensuring timely issue resolution and continuous improvement. Support regulatory inspections, customer audits, and internal quality audits at CMO or in-house facilities. Injectable site Brown Field project handling for layout finalization and strategic discussion for US plant Equipment selection for new plant as per product specifications and requirements for US plant Plant designing for handling complex injectable molecules assuring compliance as per regulatory requirements with aseptic assurance Reviewing of product process flow to handle the same at large scale production on site at US Qualification and Process validation strategies finalization for US plant product execution BMR preparation for Sterile drug product manufacturing at US plant Review of QMS documents (i.e. Change controls, Deviations, Investigations, Risk assessments) for US plant compliance SOP reviewing and finalization for Injectable facility at US Mentor and supervise team members to build functional expertise and ensure high performance.

Having 12 to 16 of relevant experience