Formulation Executive

Key Responsibilities:

Formulation development (from preformulating 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 preformulating 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 and Competencies

Formulation science and drug delivery design (solid oral, liquid, parenteral, modified release, platform technologies).

Pre-formulation and drugexcipient compatibility assessment, including interpretation of physicochemical and stability data.

Stability study design and data interpretation (ICH conditions, degradation pathways, kinetic understanding).

QbD-based development, including identification and control of CMAs and CPPs, and scale-up from lab to pilot.

Strong documentation skills for Product Development Reports, Stability Protocols, Specifications, and MFRs.

Intellectual Property and Innovation

Integration of IP strategy into formulation development and drug delivery platform design.

Ability to identify white space, generate patentable concepts, and support invention disclosures with experimental data.

Understanding of patent landscapes, prior art, and differentiation strategies at formulation and process level.

Regulatory and Compliance Skills

Preparation of scientific justifications and responses to regulatory queries (USFDA, EMA, MHRA, etc.).

Familiarity with CMC expectations for formulation development, stability, and product specifications.

Alignment of development strategies with regulatory and quality standards (GMP, data integrity).

Cross-functional and Business Skills

Coordination with Analytical R&D, QC, QA, Production, Engineering, Purchase, and Marketing.

Costing and commercial thinking for new product development (materials, process, scalability).

Vendor and stakeholder management, including organizing technical seminars and evaluations.

Leadership and People Skills

Leading and mentoring scientific teams in experimental design, problem-solving, and data interpretation.

Planning and prioritizing projects, resource allocation, and on-time delivery of development milestones.

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