Job Summary: The VP Technical Development Consultant will be responsible for overseeing and guiding technical operations, process development, and scale-up activities for small molecules, specifically solid oral dosage forms. This role requires a deep understanding of Good Manufacturing Practices (GMP), New Drug Applications (NDA), and gap analysis to ensure successful product development and commercialization.
Key Responsibilities:
- Lead and manage technical operations and process development for small molecules, focusing on solid oral dosage forms.
- Oversee the scale-up of manufacturing processes from laboratory to commercial scale, ensuring compliance with GMP standards.
- Conduct gap analysis to identify areas for improvement and implement effective solutions.
- Collaborate with cross-functional teams to develop and execute strategies for successful NDA submissions.
- Provide technical expertise and guidance on process optimization, troubleshooting, and validation activities.
- Ensure adherence to regulatory requirements and industry standards throughout the product development lifecycle.
- Mentor and develop a team of technical professionals, fostering a culture of innovation and continuous improvement.
- Stay abreast of industry trends and advancements to drive innovation and maintain a competitive edge.
Qualifications:
- Advanced degree in Chemistry, Chemical Engineering, Pharmaceutical Sciences, or a related field.
- Minimum of 10 years of experience in technical operations and process development within the pharmaceutical industry.
- Proven expertise in small molecules, solid oral dosage forms, and GMP compliance.
- Strong knowledge of NDA processes and regulatory requirements.
- Demonstrated experience in gap analysis, process scale-up, and commercialization.
- Excellent leadership, communication, and problem-solving skills.
- Ability to work effectively in a fast-paced, dynamic environment.
