Division Department Sub Department 1 Job Purpose Execute and implement the API technology transfer activities in Pilot & plant to ensure robustness of process in line with proper safety requirements Key Accountabilities (1/6) Execute scale up activities at Pilot and Plant scale, for current molecules & CIP products, to ensure safe transfer of process
• Understand the process thoroughly and map the equipment hardware most suitable for the process (Scale up/ Scale down approach)
• Involved in HAZOP study. Ensure operations at pilot & plant are implemented with recommended safety PPE for batches of new / CIP products
• Report abnormal observations during pilot batch to the pilot head, to take timely preventive actions Key Accountabilities (2/6) Monitor the Kilo, Pilot, pre-validation and validation cycle batches at Kilo, Pilot & plant. Conduct knowledge sharing training sessions for shop floor staff to ensure accurate identification of critical process parameters
• Understand the critical process and safety parameters and transfer the knowledge to pilot & plant staff via training sessions
• Monitor the in-process checks for Kilo, pilot, pre-validation, validation batches and compare the same with lab batches for any deviations
• Report the deviations, if any, to the Head of Tech Transfer
• Compile the data of pilot batches to create pilot reports while monitoring the process at pilot and provide the same to tech transfer & Mfg team Key Accountabilities (3/6) Operations & maintain highest safety standard
• Participate in HAZOP activities and prepare mitigation plan based on key identified risks in the process
• Ensured & reviewed MSDS, thermal stability, RC1 & Powder Safety data before pilot batches.




• Recommendation given to generate data if required from safety point of view.
• No fatalities Key Accountabilities (4/6) Progress on Talent & leadership
• Mentoring, trained & prepared freshers to perform job assigned strategically & systematically
• Assigned the jobs to the team members. Monitored & track job assigned
• Maintained daily & monthly Upkeep & online review of Kilo, Pilot Prevalidation & validation batches.
• Align with all the stake holders like R& D, Project Management, Research Operation Cell, EHS for Piloting & Validation activities
• Prepared slides for score card review (%RFT) of all sites Key Accountabilities (5/6) API robustness and provide inputs for equipment mapping
• Ensured API robustness on pilot level for smooth execution on plant level
• Workout methodologies in terms of process engineering to match the equipment’s, operations and quality end to end
• Compare the data of Piot & plant equipment required, if any, for engineering calculations
• Plan and monitor the API Pilot Plant activities along with technical & safety inputs to ensure implementation of robust process in plant with proper safety requirements
• Ensure right first time approach Key Accountabilities (6/6) Major Challenges
• Lack of practice to conduct negative experiments to measure deviations occurring in plant environment – To overcome,



suggest negative experiments during scale up batch for at least critical steps in the process. For other steps, identify the negative conditions and provide this information to TT team
• To ensure smooth transfer, data from Lab, Kilo and Pilot sources needs to be compared for gaps in quality at any stage; however, data received is not standard and has gaps, causing challenges in comparison – To overcome, communicate the expected data parameters and request these to teams for data well in advance. Another way is to utilize online data generated during Lab/Kilo/Pilot batches Key Interactions (1/2) Internal
• IPD R&D; to discuss process (regular)
• Pilot plant for pilot batch (regular)
• QBD team for QbD data before pilot batch execution (need based)
• Manufacturing for tech transfer (regular)
• Research Operational Cell for pilot batch (regular)
• ADL to check quality from first receipt of raw material till release of pilot batch (regular)
• Project Management for tech transfer (regular) Key Interactions (2/2) Dimensions (1/2) Monitoring Pilot & validation batch execution for 2 to 3 site locations Execution of 7 to 12 products annually Dimensions (2/2) Key Decisions (1/2) Decisions
• Batch initiation and monitoring
• In-process checks (what type of check at what stage)
• Target Yield & quality Key Decisions (2/2) Recommendations
• Critical document sign-off & Trainings
• Critical process decisions
• Resolution to hurdles during process execution (in terms of some modification in process/operation Education Qualification B. E. Chemical Relevant Work Experience Over 18 years of experience in Technology Transfer/ Process development/Product scale Up/Production Operation/Process safety with Pharmaceutical Sector

📌 Team Member (Bommasandra)
🏢 Cipla
📍 Bommasandra