Summary

Lead the scientific design and development of differentiated pharmaceutical formulations and drug delivery systems, integrating early IP strategy into all stages of development. Drive innovation by identifying white space, generating patentable formulation and process concepts, and producing robust experimental data to support strong composition, process, and use claims. Collaborate closely with cross‑functional teams and patent counsel to convert R&D outputs into protectable intellectual property and maintain a sustainable competitive advantage for the organization.

Key Responsibilities

• Lead end‑to‑end formulation development (from preformulation through lab and pilot scale) for robust, scalable, and compliant products
• Design formulation and drug delivery strategies based on literature, patent landscape, and market/innovator benchmarks
• Interpret preformulation and stability data, identify risks and degradation pathways, and drive science-based optimization decisions
• Integrate IP thinking into development by identifying white space, generating patentable formulation/process concepts, and supporting invention disclosures
• Prepare and review core technical documentation (PIF, PDR, stability protocols/reports, specifications, MFR, formulation certificates, costing)
• Coordinate cross‑functionally with Analytical R&D, QC, QA, Production, Engineering, Purchase, and Marketing to ensure seamless project execution
• Provide scientific justifications and responses to regulatory queries in line with global regulatory expectations
• Mentor and lead the formulation team, ensuring high-quality experimental design, data integrity, and continuous capability building
• Drive innovation in new drug delivery platforms and differentiated product concepts that support portfolio growth and competitive positioning

Skills Required

Formulation Development & Technical Expertise

• Formulation Science: Formulation science and drug delivery design (solid oral, liquid, parenteral, modified release, and platform technologies).
• Pre-formulation Studies: Pre-formulation and drug–excipient compatibility assessment, including interpretation of physicochemical and stability data.
• Stability Studies: Stability study design and data interpretation (ICH conditions, degradation pathways, and kinetic understanding).
• Quality by Design (QbD): QbD-based development, including identification and control of CMAs and CPPs, and scale-up from laboratory to pilot scale.
• Technical Documentation: Preparation of Product Development Reports, Stability Protocols, Specifications, and Master Formula Records (MFRs).

Intellectual Property & Innovation

• IP Strategy: Integrate intellectual property strategy into formulation development and drug delivery platform design.
• Innovation: Identify white space opportunities, generate patentable concepts, and support invention disclosures with experimental data.
• Patent Landscape: Evaluate prior art, patent landscapes, and differentiation strategies at formulation and process levels.

Regulatory & Compliance

• Regulatory Submissions: Prepare scientific justifications and responses to regulatory queries (USFDA, EMA, MHRA, etc.).
• CMC Knowledge: Familiarity with CMC requirements for formulation development, stability studies, and product specifications.
• Compliance: Ensure alignment with GMP, data integrity, regulatory, and quality standards.

Cross-functional & Business Management

• Cross-functional Collaboration: Coordinate with Analytical R&D, QC, QA, Production, Engineering, Purchase, and Marketing teams.
• Commercial Awareness: Evaluate product costing, material selection, process efficiency, and scalability for new product development.
• Vendor Management: Manage vendors and stakeholders, including organizing technical evaluations and seminars.

Leadership & People Management

• Team Leadership: Lead and mentor scientific teams in experimental design, problem-solving, and data interpretation.
• Project Management: Plan, prioritize, allocate resources, and ensure timely delivery of development milestones.
• Scientific Communication: Demonstrate strong written and verbal communication for internal reviews, management, and regulatory interactions.