Research Executive - Formulation Development

RESPONSIBILITIES

• To carry out literature survey, innovator product evaluation, drug substance evaluation and its DMF review.
• Responsible for pre-formulation, product development and establishing product stability as per the target market requirement and matching MMD profile with targeted reference product.
• To ensure QbD based product and process development along with use of Design of Experiment (DOE) wherever required.
• To ensure suitable pack selection based on product behaviour and target market.
• Responsible for stability data interpretation.
• Coordinate with CFTs (Analytical, API, Regulatory Affairs, Project Management, Procurement, Finance & Accounts, QA, CQA, QC, Production, Engineering, IPM, Technology Transfer, BD and Packaging) to ensure the targeted timelines of each project are met.
• Ensure smooth transfer of products from R&D to plant scale and perform gap analysis (technical) and provide technical support for site transfers/new launch products.
• Provide technical support for process improvement and troubleshooting on commercial batches as per requirement.
• Handle OOS/OOT/Deviation during batch execution / new launch products.
• Responsible for API variation / cost reduction batch execution as per the regulatory norms.
• Provide technical presentation at each stage of product development involving cross functional teams wherever required.
• Preparation and review of product development / technology transfer documents.

Desired Skills

• Must have experience in the formulation development team in a reputed pharma organizations.
• Process development skills and handling of equipments ensuring safety principles.
• String technical presentations skills.
• Good Communication skill and problem solving skills.
• Should be assertive, proactive, and self-driven.