Team Member - API Tech Transfer

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 new 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

1. 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
2. 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