Team Member - Formulation Tech Transfer
Division
Department
Sub Department 1
Job Purpose
Execute technology transfer activities in the plant in order to ensure successful transfer to commercial plant in line with defined safety norms, cost, quality and delivery timelines for new product registrations driving on time commercial launch
Key Accountabilities (1/6)
Perform effective transfer of knowledge about the process to formulations manufacturing team with required documentation for successful implementation of new molecule process
- Calculate and propose Batch size based on equipment availability and appropriate occupancy, in line with regulatory requirements, API availability and IPD budget
- Perform the execution of product transfer activities till successful submission to plant
- Review the procurement guideline, analyse the input required and plan for their availability
Key Accountabilities (2/6)
Review FMG & AMG and relevant product transfer documents to identify and remove errors
- Review CMA, CPP, CQA and limits for same, and send comments for correction if any
- Check process feasibility for execution of the batches at unit considering available resources
- Identify additional requirements for new product
Key Accountabilities (3/6)
Review batch documents and initiate procurement of prerequisites for batches execution to ensure alignment with 6M Planner and Target filling date
- Review Master SAP data BOM/Recipe/PV, Master Batch Manufacturing Record (MBMR), Master Manufacturing Formula (MMF), Master Batch Packing Record (MBPR), Process flow sheet, Equipment flow diagram, etc.
- Initiate/evaluate change request and deviation (wherever required)
- Calculate and tabulate for quantity of API, excipient and PM required for feasibility, assessment and registration batches
- Initiate procurement of API, Excipients and PM as per requirements
- Initiate procurement and tooling for accessories and change parts
- Raise indent for specific prerequisites
Key Accountabilities (4/6)
Participate in batch execution (feasibility, registration, assessment, validation, query response and first three commercial batches) to ensure smooth execution
- Resolve process challenges in batch/s execution with summary of changes or with deviation
- Reconcile yield at each stage of manufacturing and packing
- Compile Gap analysis for commercial launch of product
- Execute batch/s for CIP and AVD initiatives
Key Accountabilities (5/6)
Compile batch and process data including analytical and stability for RBDR (registration batches documents review) to perform comparisons and compilations
- Compile data for executed batches w.r.t. formula, process, in-process parameters, physical and analytical parameters
- Compile analytical data of input API and functional excipients
- Participate in investigations for OOS/OOT & Deviations
Key Accountabilities (6/6)
Provide technical inputs for regulatory deficiencies in order to support RA to respond to queries efficiently
- Share technical input for regulatory query response
- Execute amendment batch/s for the query response (if any)
Monitor the R&D and feasibility batches at Pilot plant to understand the process
- Participate in the batch/s execution at location pilot plant
- Compile and evaluate physical, process and in-process data of pilot batches
- Compile learnings and corrective actions
Major Challenges
- Delay in execution due to unavailability of manufacturing slot considering the priority of commercial products as per sales order
- Delay in QC release due to unavailability of analysis slot considering the priority of commercial products as per sales order
- Delay and hold of activity due to process/parameters deviation (if any) in the batches
- Loss of efforts and productivity due to project dropped after batches execution and stability study incubation
Key Interactions (1/2)
- At Unit:
- Stores: follow-up for the material availability, release, retest, expiry, code to code transfer activity etc. (regular)
- QC: follow-up for raw material and batch release, at each stage of manufacturing and packing (regular)
- QA: follow-up for batch document approvals and issuance, batch release approval, line clearance for the manufacturing at each stage of manufacturing (daily)
- Manufacturing: for planning and execution
- At IPD:
- FND: for stage gate process and batch execution (daily)
- ADL: for method transfer and analytical results OOS etc. (regular)
- RA: for RBDR and query response (need based)
Purchase: follow up for delivery schedule (regular)
Key Interactions (2/2)
- Supplier for punch sets, spare parts, change parts etc. (need based)
Dimensions (1/2)
- Develop execution plan and drive successful process as per IPD planner for:
- Registration batches
- Feasibility batches
- Assessment/Query response batches
- Variation batches
- Commercial launch batches
- Placebo for analytical batches
- Placebo for change parts trial
Dimensions (2/2)
Key Decisions (1/2)
Batch size finalisation
Batches execution parameters (like Wet granulation end point, LOD during drying, hardness and other critical parameters, etc.)
Key Decisions (2/2)
Initiation of Batch Destruction approval process
Code transfer
Investigation and CAPA
Packaging change parts
Education Qualification
B.Pharm / M.Pharm
Relevant Work Experience
2-5 years of experience in technology transfer for a pharma company