Team Member - Formulation Tech Transfer

Accountability Cluster

Major Activities / Tasks

1. Conduct effective transfer of knowledge about the product and process to formulations manufacturing unit with required documentation for successful implementation of new product technology

• Identify areas of improvement for product/ process development during stage gates process viz. SRM, FRM, ESM, RDBR and DRM, in assistance with Team Lead
• Study QbD phases to identify improvements for product/ process development along with team lead
• Implement mitigation plan for failure modes

2. Identify and list requirements and   prerequisites (RM, PM, tooling, accessories, machines, etc.) for execution of batches as per monthly rolling plan

• Identify the prerequisites required for the execution of process and provide the list to team lead
• Raise indents for materials with Purchase team to get pre-requisites delivered on time
• Monitor stocks and release status for API, excipients, and packaging material
• Raise indent for Capex items such as tooling & change parts

3. Participate in execution of placebo, feasibility, assessment, regulatory and amendment batches within defined timeframe

• Prepare the draft for master batch manufacturing/ packing records and assessment protocols
• Gather product and process knowledge by executing batches
• Execute regulatory batches to maintain stability
• Maintain compliance to the 6 month rolling plan
• Calculate optimum batch size for feasibility, assessment, and exhibit batches

4. Gather and collate batch, process, in-process, physical, analytical and stability data for dossier compilation

• Prepare the performance report of executed batches
• Compare batch data / parameters with identified CPPs as per design space
• Evaluate trends and stability data
• Prepare summary of changes, deviations and change request form during batch execution

5. Assist in evaluation and extrapolation of acquired batch data during the transfer process, to define control strategy for commercial launch

• Provide input data for comparison of process and in-process data against control strategy for QbD phase 3 and phase 4 document
• Conduct gap analysis for commercial launch to define action plan & ensure to comply regulatory commitments
• Execute and generate batch data for assessment/ amendment batch/s for deficiency response
• Provide required support for execution of commercial launch

6. Extend technical support to implement CIP, AVD and site transfer activities to drive product life cycle management for sustained growth

• Propose &/or review CIP activities and extend technical support in defining action plan for implementation
• Execute activities for AVD initiatives
• Collate data for filing variation through execution of variation batches
• Execute the changes as defined in change control procedure

7. Participate in Tech Transfer activities at CMO for new products

• Provide data for gap analysis to evaluate technical capabilities
• Extend required technical support in execution of feasibility, assessment and regulatory batches
• Provide inputs on batch size with equipment flow

• Getting manufacturing slot and support, may be difficult due to varied priorities for commercial execution – To overcome, trade off decisions need to be taken with least business impact
• Process variables are not adequately challenged in feasibility/assessment batches casing uncertainty in certain aspects
• Dependencies on cross functional teams (such as QA/QC) and delay in execution from their end causes overall delay in process execution – To overcome, continuous follow-ups required with concerned team
• Procedure for seeking budgetary approval for implementation of new technologies not defined clearly leading to higher approval time
• Frequent changes in strategy and product specifications during transfer due to inadequate evaluation and constraints in time line
• Infrastructure constrain, including analytical testing laboratory, to evaluate CIP and AVD initiatives

Internal

External

• IPD Formulation development team for stage gate & batch execution (Regular)
• Pilot plant to evaluate process and scale up aspects (Regular)
• QBD team for QbD evaluation (Regular)
• Quality control for batch data and stability data evaluation, specifications availability (Regular)
• EHS to seek guidance (Need based)
• Engineering to implement Capex, and seek guidance (Need based)
• Manufacturing to plan and execute batches (Regular)
• Regulatory Affairs to review RA strategy, RBDR, DRM and Deficiency response plan (Regular)
• Purchase to pursue and evaluate vendor (Need based)

• Contract manufacturing organisation to provide technical support in technology transfer (Need based)

• Responsible for execution of ~30 new projects annually from IPD including commercial launch
• Responsible for transfer of technology for solid, sterile, ophthalmic, respiratory and speciality products (Anti-cancer, Hormones and lyophilized products)
• Provide timely technical support for transfer to CMO