Formulator

Posting Date: May 27, 2025

Department: R&D Formulations

Business Unit: Integrated Product Development

Country: India

State: Maharashtra

Location: Vikhroli

Req Id: 94723

Division

Department

Sub Department 1

Job Purpose

Execute end to end formula and process development of products following good laboratory practices and continuously monitor its data and quality to have robust a product within the budget, timeline and regulatory standards

Key Accountabilities (1/6)

Collate and review Pharma literature from USFDA etc. in order to utilize knowledge during product development

Perform literature search from USFDA and regulatory websites, pharmacopoeia etc.

Key Accountabilities (2/6)

Provide and submit all stage gates documents to CFT on the basis of data generated from development trials to execute batches at plant

Prepare all stage gates documents which include QbD documents (Stage I, II, III), SRM, FRM and ESM slides and development protocol for filling
Design product development strategy using hands on technical knowledge, literature search and risk assessment to have a plan of action with timelines

Key Accountabilities (3/6)

Gather data from pre-formulation studies by carrying out characterization of reference product and optimize the formula in order to develop a robust product

Develop the formula or process of an existing product by carrying out experiments, reviewing historical data and specifications and comparing with the reference product in order to improve quality or reduce the manufacturing time of the existing product

Key Accountabilities (4/6)

Provide indent through supply chain management to procure the Filters, RM and PM required during product development and submission batches

Provide indent for raw material and packaging material
Prepare manufacturing guideline, FPS, PDCL, PAF, Data sheet, RMCA code request, Test license requirements, mfg. licence communication, DCGI NOC request, TT report preparation and DP
Compile and assess data generated during the development cycle through review and discussions to study the trend of the product performance and its quality

Key Accountabilities (5/6)

Prepare regulatory submission data by conducting R&D trials and executing regulatory submission batches at the unit for successful filing

Conduct compatibility studies and generate data to propose MOC and vendors for filter, tubingâs and manufacturing vessels
Conduct lab batches for Prototype process and formulae development
Prepare stability batches and generate stability data with finalized prototype formulation for submission to the regulatory agency

Key Accountabilities (6/6)

Provide deficiency response support by generating data at R&D/Unit required for approval of the product

Prepare AMG to implement changes required for the preparation of commercial BMR
Undertake deficiency response involved data generation at R&D for submission to regulatory agency
Submit batches for extra characterization, E&L study, force degradation study etc.

Major Challenges

Delay in approval of documents due to multiple approval levels in cipdox

Overcome by: activity can be completed out of cipdox software

Non availability of slots at unit leading to delay in timelines

Overcome by: slots availability can be ensured for proposed date of execution)

Non feasible product identification leads to delay in timelines, product hold, involves huge cost and leads to revenue sharing with CMO
Overcome by: Feasibility report for the execution of product at R&D and unit can be prepared which includes requirement of machine, capex etc.

Key Interactions (1/2)

ADL department for analytical data (daily)
Supply chain department for RM and PM (daily)
QbD department for stage gates documents preparation (as per need basis)
Regulatory department for stage gates and deficiencies (weekly)
IPM department for PPAR discussion and patent oriented issue discussion (as per need basis)
DQA department for product review before filing (as per need basis)
Jaagruti department for number of batches calculation/month (monthly)

Key Interactions (2/2)

Filter, equipment vendors for execution and procurement (as per need basis)
RM and PM vendors for execution and procurement (as per need basis)

Dimensions (1/2)

Development of 2-4 projects/year depending upon complexity
Develop products with non-failure during regulatory and commercial batches
Development of product with zero deficiency target

Dimensions (2/2)

Key Decisions (1/2)

Recommendation for proper choice of RM, PM, Filters, instruments evaluated during product development and communicated to plant for execution of regulatory and commercial batches

Recommendation during planning of developmental trials at R&D

Recommendation in manufacturing process during preparation of manufacturing guidelines