Sr. Executive/Assistant Manager New Product Development

The role involves evaluating, designing, planning, and monitoring new product development projects to ensure timely achievement of key milestones. The candidate will be responsible for optimizing formulation compositions, manufacturing process parameters, and critical quality attributes (CQAs). Additionally, the role requires reviewing, maintaining, and controlling all product development documentation in compliance with regulatory standards. Supporting activities related to successful product registration and commercialization is also a key aspect of this position.

Key Responsibilities:
- Design and develop pharmaceutical products aligned with the Quality Target Product Profile (QTPP) and regulatory requirements.
- Conduct product feasibility assessments, literature reviews, innovator product evaluations, and technical risk assessments for new product development projects.
- Prepare and implement development strategies covering formulation, process, packaging, and stability studies.
- Plan and execute pre-formulation, formulation optimization, process optimization, and scale-up activities.
- Perform root cause analysis to address development challenges and implement corrective actions to meet desired product quality attributes.
- Coordinate technology transfer activities from R&D to manufacturing for commercial production.
- Ensure compliance with current Good Manufacturing Practices (cGMP), ICH guidelines, Pharmacopoeia standards, and internal quality systems throughout all development phases.
- Support and coordinate comprehensive project plans for new product development activities from concept initiation through commercialization.

Required Qualifications:
- Master’s or Bachelor’s degree in Pharmacy (Pharm-D, M. Pharm).
- Solid understanding of pharmaceutical product development principles for various dosage forms.
- Familiarity with Quality by Design (QbD), Risk Assessment, and Process Development concepts.
- Knowledge of excipient functionality, active pharmaceutical ingredient (API) characteristics, compatibility studies, and formulation strategies.
- Understanding of pharmaceutical manufacturing processes, including scale-up principles and commercial manufacturing requirements.
- Thorough knowledge of relevant ICH guidelines, cGMP requirements, and regulatory expectations from agencies such as FDA, EMA, WHO, along with Pharmacopoeia standards.

Preferred Qualifications and Experience:
- 3 to 5 years of relevant experience in a reputable pharmaceutical company.
- Hands-on experience or knowledge in product development, technology transfer, and commercialization of pharmaceutical products.
- Experience in managing regulatory and GMP-related documentation.

This position offers the opportunity to work in a dynamic environment focused on innovation and quality within the pharmaceutical industry, contributing directly to the successful launch of new products in compliance with global regulatory standards.