F&D Manager / Senior Manager (Complex Injectables)

Role & responsibilities

1. Formulation Development:
• Lead and oversee the end-to-end development of complex injectable formulations, including depot and lipo formulations, for regulated markets such as the US, EU, and other regulated regions.
• Design and optimize formulation strategies for novel and generic injectable products, ensuring alignment with regulatory and quality standards.
2. Project Management:
• Plan, execute, and manage formulation development projects, ensuring timely delivery within budget and meeting regulatory requirements.
• Collaborate cross-functionally with teams such as analytical development, regulatory affairs, and manufacturing for seamless technology transfer and scale-up.
3. Regulatory Compliance:
• Prepare and review technical documentation, including development reports, master formula records, and regulatory filings (e.g., ANDAs, NDAs, MAAs).
• Stay updated with the latest regulatory guidelines and ensure compliance with USFDA, EMA, and other regulatory standards.
4. Innovation and Research:
• Explore and implement innovative approaches in formulation development for complex injectables, including drug delivery systems.
• Work on identifying and resolving technical challenges in developing depot/lipo formulations.
5. Team Leadership:
• Lead, mentor, and guide a team of scientists and associates to achieve project goals.
• Build technical capabilities within the team and promote a culture of continuous learning and excellence.
6. Technology Transfer:
• Drive smooth technology transfer of formulations from R&D to commercial manufacturing sites.
• Collaborate with manufacturing teams to resolve any technical issues during the scale-up and commercialization phases.
7. Stakeholder Collaboration:

Work closely with internal and external stakeholders, including CROs, CMOs, and regulatory agencies, to ensure project success

• Educational Qualification: M.Pharm / Ph.D. in Pharmaceutics or a related discipline.
• Experience: Minimum 10 years of experience in formulation development for complex injectables, particularly depot and lipo formulations, targeting regulated markets such as the US and EU.
• Technical Expertise:
• Proven track record of developing and filing complex injectable products.
• Expertise in working with depot formulations, liposomal drug delivery systems, or similar technologies.
• Strong understanding of regulatory requirements for injectable products in regulated markets.
• Soft Skills:
• Excellent leadership, communication, and project management skills.
• Analytical problem-solving ability and attention to detail.