Assistant Manager - Formulation & Development

Role Summary

This role demands a strong background in developing and refining semisolid dosage forms like ointments, creams, and gels. The incumbent will focus on designing formulations that meet quality, stability, efficacy, and regulatory standards, especially targeting EU, semi-regulatory, and Rest Of World (ROW) markets.

Key Responsibilities

• Lead formulation development and optimization for semisolid products ensuring robust quality and compliance.
• Manage planning and execution activities related to formulation and development (F&D).
• Develop semisolid formulations in line with European Union regulatory requirements and other markets.
• Prepare comprehensive CTD (Common Technical Document) and Quality by Design (QbD) documentation for regulatory submissions.
• Achieve development goals within set standards while controlling material usage and ensuring product quality.
• Procure all necessary raw and miscellaneous materials timely as per project requirements.
• Organize technical and behavioral training sessions for department staff to aid professional growth.
• Conduct drug-excipient compatibility and stability studies following ICH guidelines.
• Oversee technology transfer processes coordinating with related departments, ensuring documentation, protocol adherence, and reporting are in place.
• Ensure strict adherence to regulatory guidelines throughout formulation activities.
• Prepare and execute master formulation cards and product development reports as part of CTD submissions.
• Collaborate with QA/QC, production, and regulatory teams to ensure timely product delivery.

Additional Information

Orchid Pharma is a reputed pharmaceutical company listed on the Bombay Stock Exchange, re-established in the Indian formulations market focusing on hospital segments, with a critical care division dedicated to injectable antibiotics and antifungals. The manufacturing facilities include USFDA-approved plants for Cephalosporins.