Assistant Manager

Job Description

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.