Job Summary: Product Development & Site Execution Lead R&D;

This role ensures seamless execution of pharmaceutical product development from feasibility to dossier submission, while coordinating cross-functional teams and regulatory compliance.

KEY RESULT AREAS/PRIMARY ACTIVITIES WITH PERFORMANCE INDICATORS

Main activities or responsibilities of the job and the end result the job is expected to achieve.

Development

- To ensure feasibility analysis of Recent Product Proposal with respect to manpower, materials, machinery and cost
- To prepare product budget i.e. considering commercial, development and technical feasibility
- To decide project timelines and publish it in EPM and monitor it throughout the project
- To ensure various clearances and certifications from Regulatory bodies and other agencies for development projects
- To coordinate with Purchase Dept. and ensure procurement of API, KSM, Excipients, consumables standards, impurity, column and International Finished Formulation IFF
- To minimize bottlenecks by timely intervention so as to ensure smooth and timely lab scale development
- To finalize CRO on the basis of cost comparison, criticality and method availability criteria for Pilot Bio and Pivotal Bio
- To ensure effective run of EPMS i.e., tracking man-hours and updating completion of project activities
- To prepare months MIS of total budget and Project Status to be presented to Business Head
- To conduct Product Extension feasibility analysis in other markets w.r.t regulatory guidelines, exhibit batch, bio point of view etc.
- To assist in variance analysis of monthly MIS from commercial
- To present product development status to team members and business heads during monthly and quarterly project reviews respectively
- To ensure timely submission of all dossiers from Quality department
- To handle regulatory queries and timely address the same
- To conduct project reviews development phase wise (Literature review, Strategy Review – Review 0, Review 1, 2, 3 and 4; both API & Formulation)
- To coordinate with Plant,



marketing, Finance and other departments to do costing of formulation & API for launch year and current year.

Site PDG

- To ensure timely pilot bio batch plan to PPC and budget the manufacturing load in PDL, EBA & commercial area.
- To ensure proper monthly Exhibit batch / Scale up / FnD Trial / Optimization batch plan to plant PPC based on Priority/readiness for execution.
- To ensure slot availability timely completion of the plan.
- To ensure availability of all the plant documents i.e. BMR, PVP, Hold time protocol, BPR, Stability protocols, Form 32 site approval, etc as per Exhibit batch execution plan.
- To ensure proper planning and prioritizing the cleaning validation (CV) / Analytical method validations (AMV) /Verifications (AMVe) for Finish Product/API/Excipients in co-ordination with plant QC and facilitate availability of all pre-requisites i.e samples, Impurity/column/instrument, etc. for timely completion of validation/verification activities.
- To ensure proper planning, tracking and facilitating the execution of Exhibit batches and ensuring timely stability loading with due co-ordination with PPC/FFT/Production/QA/QC/RM store/PKG for various functions like Manufacturing PO, Pkg PO, dispensing, exhibit sample testing & release, Batch records release, packing planning, Stability loading, etc.
- To ensure proper co-ordination with Plant QC to plan and prioritize Exhibit batch samples, Raw material and packing material testing and release
- To ensure proper co-ordination and handling plant related activities to timely address Regulatory Queries like Analytical method validation (AMV) /verification (AMVe) / transfer (AMT), API/FP/Excipient CoA generation, Pharmacopeia updation, Plant document revision, Stability data availability, ongoing stability sample arrangement, etc in co-ordination with PPC/FFT-TR/QC/QA/RM store
- To ensure proper closure of OOS/Deviations observed in Exhibit batches in co-ordination with all stake holders
- To ensure plant documents availability for timely Dossier submissionRole & responsibilities

Preferred candidate profile

📌 Torrent Pharma - job opening For PDG (Project Development Group) (Gandhinagar)
🏢 Torrent Pharmaceuticals
📍 Gandhinagar