Drug Product Project Leader
On-siteHyderabad, Telangana, India
Job Summary
Lead and manage all Drug Product (DP) related technical development activities for assigned oral small molecule projects, representing DP teams in Technical Research and Development sub-teams. Formulate project strategy including contingency planning and risk assessments, ensuring alignment with Pharmaceutical Development and external stakeholders. Execute smart DoE and scale-up/transfer campaigns to establish robust manufacturing processes suitable for human trials and commercial supplies, while creating high-quality development documents for CMC submissions and registration dossiers. Assess resource needs, negotiate timelines, and ensure adherence to scientific review processes and regulatory guidelines.
Required Qualifications
- PhD in Pharmaceutical Sciences
- 8+ years of experience
- MTech/M.Pharm in Pharmaceutical Technology/Pharmaceutics or relevant scientific field
- 12+ years of relevant technical experience in Development of oral Pharmaceutical Drug Products
- proven experience in leading project teams
- Successfully demonstrated expertise in pharmaceutical oral dosage form development and manufacturing
- formulations for Small Molecules including development, technology transfer and manufacturing
- An in-depth understanding of material science principles, as applied to oral dosage forms
- impact of physico-chemical properties of API and excipients on the drug product process and quality
- Extensive experience with application of Quality by Design
- Quality risk management principles and tools
- strong working knowledge of regulatory guidelines relevant to Drug Product Development
- validation, risk management, testing and stability
- Experience in applying data science, statistics, and DoE to enhance pharmaceutical development
- providing a robust framework for data analysis, experimental design, and decision-making
- Strong knowledge of laboratory and/or technical tools
- pharmaceutical manufacturing technologies
- knowledge of relevant GLP, GMP regulations and policies
- Strong presentation/communication and scientific/technical writing skills
- Strong collaboration and stakeholder management skills in global environment
Desired Qualifications
- Data Science
- Materials Science
- Process Simulation
- Technical Writing
- Waterfall Model
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