Sr. Executive / Assistant Manager - New Product Development

About the role

This role evaluates, designs, plans and monitors new product development projects so that product development milestones are met on time. It covers optimisation of formulation composition, manufacturing process parameters and critical quality attributes (CQAs), review and control of product development documentation in line with regulatory requirements, and support of product registration and commercialisation.

Key responsibilities

• Design and develop pharmaceutical products in line with the Quality Target Product Profile (QTPP) and regulatory requirements.
• Carry out product feasibility assessments, literature reviews, innovator product evaluations and technical risk assessments.
• Prepare and run development strategies for formulation, process, packaging and stability studies.
• Plan and execute pre-formulation, formulation and process optimisation, and scale-up activities.
• Perform root cause analysis of development challenges and implement corrective actions.
• Coordinate technology transfer from R&D to manufacturing.
• Ensure compliance with cGMP, ICH guidelines, Pharmacopoeia and internal quality systems.
• Support project plans from concept initiation through commercialisation.

Required profile

• Master's or Bachelor's degree in Pharmacy (Pharm-D, M. Pharm).
• 3-5 years of relevant experience in a reputable pharmaceutical company.
• Hands-on experience in product development, technology transfer and commercialisation.
• Experience handling regulatory and GMP-related documents.

Required skills

• Understanding of QbD, risk assessment and process development.
• Knowledge of excipients, APIs, compatibility studies and formulation strategies.
• Knowledge of ICH guidelines, cGMP, FDA, EMA, WHO and Pharmacopoeia requirements.