Formulation and Development Executive

Key Responsibilities

Design and develop formulations for generic drug products (solid orals) Conduct pre-formulation and formulation studies, including excipient compatibility and stability testing. Experience in technology transfer Execute trial batches, scale-up, and exhibit batches as per QbD principles. Prepare and review Master Formula Records (MFR), Batch Manufacturing Records (BMR), and technology transfer documents.

Coordinate with cross-functional teams (QA, QC, Regulatory, Production) during development and tech transfer. Participate in process validation and exhibit batch manufacturing. Handle troubleshooting during scale-up and validation at the plant level. Prepare product development reports and regulatory documentation as per MHRA/ICH/WHO guidelines.

Ensure adherence to data integrity and GMP practices in all documentation and operations. Support regulatory filing documentation (e.g., CTD modules, product dossiers).

Requirements

B.Pharm / M.Pharm – Pharmaceutics / Industrial Pharmacy Sound knowledge of MHRA, ICH, QbD, and cGMP regulations Proficient in documenting and reviewing technical reports and protocols Skills & Competencies: Strong analytical and problem-solving skills Good communication and coordination abilities Knowledge of regulatory guidelines (MHRA, EU-GMP) Attention to detail and commitment to quality