Role & responsibilities
1. Team Leadership and Project Management :
- Lead a team of scientists in the design and development of injectable formulations, providing technical guidance and mentorship.
- Manage multiple formulation development projects, ensuring that timelines, budgets, and deliverables are met.
- Assign tasks, monitor progress, and provide feedback to team members to ensure high-quality project execution.
2. Formulation and Process Development :
Oversee the development and optimization of various injectable formulations (e.g., solutions, emulsions, suspensions, lyophilized products).Provide expert input on pre-formulation studies, excipient selection, and formulation optimization.Lead process development activities, including filtration, sterilization, and aseptic processing for injectable formulations.3. Technology Transfer and Scale-Up :
Oversee the scale-up and transfer of injectable formulations from laboratory to pilot and commercial-scale production.Collaborate with manufacturing teams to ensure smooth technology transfer, addressing any process-related challenges.Lead process validation activities in preparation for commercial manufacturing.4. Lyophilization Development :
Lead the development of lyophilization cycles for freeze-dried injectable products, ensuring robust, reproducible processes.Provide strategic guidance on the use of thermal analysis tools and other techniques for lyophilization process optimization.5. Collaboration with Cross-Functional Teams :
Work closely with departments such as Analytical, Regulatory, Quality Assurance, Clinical, and Manufacturing to ensure seamless integration of formulation development into the overall product development process.Participate in cross-functional team meetings to provide updates on progress, challenges, and strategic input.6. Regulatory and Compliance Oversight :
Ensure all formulation development activities comply with cGMP, ICH, and FDA guidelines.Oversee the preparation and review of technical documentation, including protocols, reports, batch records, and regulatory submissions (IND, NDA, ANDA).Work closely with Regulatory Affairs to ensure alignment with submission requirements and timelines.7. Innovation and Strategy :
Drive innovation in formulation development by keeping up-to-date with advancements in drug delivery technologies, excipient usage, and sterile product manufacturing processes.Provide input on long-term strategy for injectable product development, aligning departmental goals with the companys broader objectives.Identify opportunities for cost-effective development strategies without compromising product quality or regulatory compliance.8. Data Analysis and Risk Management :
Lead the design and execution of experiments, including statistical design of experiments (DoE), to optimize formulations and processes.Analyze data generated from development studies to inform decisions on formulation stability, process improvements, and product specifications.Develop and implement risk mitigation strategies to address potential issues related to formulation stability, scale-up, and regulatory challenges.9. Stability and Analytical Collaboration :
Work with the Analytical Development team to develop and validate analytical methods for injectable formulations.Ensure robust stability testing protocols are in place to monitor the performance of formulations under ICH conditions, identifying and addressing any stability issues.Preferred candidate profile
Experience with complex injectables, including biologics, liposomal formulations, or microspheres.Familiarity with lyophilization development and scale-up processes.Experience working in a cGMP-compliant environment and leading interactions with regulatory agencies.Willing to Relocate in Indore, M.P.Skills Required
biologics , Frd, lyophilization, Innovation, Data Analysis, Risk Management