R&D Formulations - Complex Injectables & Biosimilars - DGM

Biological E; New Delhi; On-site; INR 2,500,000 - 4,200,000; Full time

Job summary

Biological E in India seeks a Head of Formulation Development to lead complex injectable formulations and biosimilars from selection to commercialization, driving cross-functional strategy across CMC, regulatory, IP, tech transfer, and portfolio management.

You will guide development of Liposomes, LNPs, biosimilars, LAIs, microspheres, and depot systems; oversee process development, QbD, risk-based approaches, tech transfer, vendor assessments, and GMP-compliant execution across R&D,

Responsibilities

• Lead development of Liposomes, LNPs, Biosimilars, LAIs, Microspheres, and Depot formulations.
• Guide formulation optimization, process development, and scale-up activities.
• Drive QbD- and risk-based development approaches.
• Resolve critical formulation, process, and analytical challenges.
• Ensure robust product characterization and stability strategies.
• Define regulatory pathways and filing strategies for global markets.
• Evaluate patent landscape and freedom-to-operate opportunities.
• Develop non-infringing formulation strategies.
• Review CMC documentation for regulatory submissions.
• Provide scientific responses to regulatory queries.
• Lead cross-functional project teams.
• Drive phase-gate reviews and project governance activities.
• Monitor project milestones and implement risk mitigation plans.
• Ensure timely reporting to senior management.
• Facilitate collaboration across R&D, Regulatory, Quality, Manufacturing, and IP teams.
• Lead technology transfer and commercialization activities.
• Assess manufacturability and scalability of formulations.
• Perform technical due diligence of CMOs/CDMOs.
• Support external development and in-licensing opportunities.
• Provide technical support for commercial products.
• Ensure compliance with GMP, ICH, and quality system requirements.
• Maintain audit readiness of Formulation R&D laboratories.
• Ensure timely closure of audit and compliance observations.
• Promote data integrity and quality culture across projects.
• Review development costing for portfolio selection.
• Prepare and manage departmental Capex and Opex budgets.
• Optimize resource allocation and project investments.
• Support strategic planning and capability-building initiatives.
• Build and mentor high-performing scientific teams.
• Foster innovation, collaboration, and technical excellence.
• Develop future leaders and subject matter experts.

Job description

Head - Formulation Development (Complex Injectables & Biosimilars)

Position Summary

Lead the development of complex injectable products and biosimilars from product selection to commercialization. Provide scientific, strategic, and operational leadership across formulation development, CMC strategy, regulatory filings, IP assessment, technology transfer, and portfolio management.

Formulation Development & Scientific Leadership

• Lead development of Liposomes, LNPs, Biosimilars, LAIs, Microspheres, and Depot formulations.
• Guide formulation optimization, process development, and scale-up activities.
• Drive QbD- and risk-based development approaches.
• Resolve critical formulation, process, and analytical challenges.
• Ensure robust product characterization and stability strategies.

Regulatory, IP & CMC Strategy

• Define regulatory pathways and filing strategies for global markets.
• Evaluate patent landscape and freedom-to-operate opportunities.
• Develop non-infringing formulation strategies.
• Review CMC documentation for regulatory submissions.
• Provide scientific responses to regulatory queries.

Project & Stakeholder Management

• Lead cross-functional project teams.
• Drive phase-gate reviews and project governance activities.
• Monitor project milestones and implement risk mitigation plans.
• Ensure timely reporting to senior management.
• Facilitate collaboration across R&D, Regulatory, Quality, Manufacturing, and IP teams.

Manufacturing & External Collaborations

• Lead technology transfer and commercialization activities.
• Assess manufacturability and scalability of formulations.
• Perform technical due diligence of CMOs/CDMOs.
• Support external development and in-licensing opportunities.
• Provide technical support for commercial products.

Quality & Compliance

• Ensure compliance with GMP, ICH, and quality system requirements.
• Maintain audit readiness of Formulation R&D laboratories.
• Ensure timely closure of audit and compliance observations.
• Promote data integrity and quality culture across projects.

Financial & Resource Management

• Review development costing for portfolio selection.
• Prepare and manage departmental Capex and Opex budgets.
• Optimize resource allocation and project investments.
• Support strategic planning and capability-building initiatives.

People Leadership

• Build and mentor high-performing scientific teams.
• Foster innovation, collaboration, and technical excellence.
• Develop future leaders and subject matter experts.

Drive a performance-oriented and learning-focused culture.