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Assistant Manager / Group Leader- FRD

Assistant Manager / Group Leader- FRD

ConfidentialPithampur, Indore
30+ days ago
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.

    • Skills Required

    biologics , Frd, lyophilization, Innovation, Data Analysis, Risk Management

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    Assistant Manager • Pithampur, Indore