Executive

Glenmark Pharmaceuticals; Solan; On-site; INR 900,000 - 1,500,000; Full time

Job summary

Glenmark Pharmaceuticals in Solan, Himachal Pradesh, India, is seeking an experienced professional to lead process development, technology transfer and scale-up for drug products. The role focuses on robustness, manufacturability and successful product introduction.

You will coordinate with R&D, PD/L and production teams for development, exhibit, validation batches and new launches, bridging development to manufacturing while ensuring absorption of complete technology on the shop floor and

Qualifications

• Experience in process development and scale‑up for pharma products.
• Strong knowledge of technology absorption, product transfer and process optimization.
• Experience with PPQ/validation batches and tech transfer to manufacturing.

Responsibilities

• Coordinate with R&D/PDL/Production for development, exhibit, process validation batches and new launches.
• Bridge development and ensure absorption of complete technology for new/transferred products to shop floor.
• Monitor process performance and resolve technical product issues during new product introductions and site transfers.
• Oversee process capability (Cpk/Ppk) and ensure robustness before commercialization.
• Review critical process parameters and support for BPR parameter finalization and variability detection.

Skills

Process development

Tech transfer

Scale-up

Process validation

Quality & compliance

Tools

DOE

Statistical analysis

Process capability (Cpk/Ppk)

Job description

Job Description

Comprehensive understanding of scale up, technology absorption, Product transfer, process optimization, product robustness and process performance qualification operations.

Job Description

Comprehensive understanding of scale up, technology absorption, Product transfer, process optimization, product robustness and process performance qualification operations.

Ensure scientific assessment into the Manufacturability, robustness, scalability and suitability for the available equipment at facility for the drug products introduced at sites and guide team for robust process development during new product introduction.

Technical coordination with R&D/PDL/Production team for execution of Development/Exhibit/Process Validation batches/New Launches.

Bridge with development and ensure absorption of complete technology of new/transferred products from R&D/PDL and same to be extended to shop floor for smooth commercialization as well as ahead-of-schedule escalation of challenges with resolution plan.

Ensure monitoring of process performance and competent resolution of technical product issues of all new product introductions/site transfers/ Re PPQ programme at the site to ensure manufacturability of products in the available equipment train in line with equipment occupancy, capability, and qualification ranges.

Oversee all aspects of technical manufacturing processes & manufacturability of products including process capability (Cpk & Ppk) to ensure the robustness of existing products and new/transferred products before commercialization from the site.

Review of critical process parameters, support finalization of BPR parameters, support for assessment & detect the variability, identification & resolution of issues, and timely escalation of challenges of all new products after scale-up/exhibit/validation batches to ensure manufacturability& compliance to limits/specifications during commercial manufacturing.