Assistant Manager / Group Leader- FRD

The purpose of this role is to :-.

The Group leader of Formulation and Development (Injectables) will oversee the design, development, and optimization of sterile injectable formulations. This role will lead a team of scientists and collaborate closely with cross-functional teams, including Analytical, Regulatory, Quality, and Manufacturing, to ensure successful formulation development, scale-up, and commercialization of injectable products. The Manager will also provide strategic direction, ensuring that all projects align with organizational objectives and regulatory requirements.

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.