Sr. Executive/Assistant Manager New Product Development

This role involves evaluating, designing, planning, and monitoring new pharmaceutical product development projects to ensure timely achievement of milestones. The candidate will optimize formulation composition, manufacturing process parameters, and critical quality attributes (CQAs). Additionally, they will be responsible for 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 part of this position.

Key Responsibilities:
- Design and develop pharmaceutical products in alignment 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 requirements, and internal quality systems throughout all development phases.
- Coordinate and support comprehensive project plans for new product development (NPD) from concept initiation through commercialization.

Required Qualifications:
- Master’s or Bachelor’s degree in Pharmacy (Pharm-D, M. Pharm).
- Strong 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, API characteristics, compatibility studies, and formulation strategies.
- Understanding of pharmaceutical manufacturing processes, scale-up principles, and commercial manufacturing requirements.
- Thorough knowledge of relevant ICH guidelines, cGMP requirements, FDA, EMA, WHO, and other international regulatory expectations, including Pharmacopoeia standards.

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

This position offers the opportunity to work on cutting-edge pharmaceutical product development projects within a regulated environment, contributing directly to the successful launch and commercialization of innovative products.