Formulation & Process Development Scientist

We are looking for:

A Formulation Scientist to be responsible for formulation and process development activities from early development through scale-up, validation, and technology transfer. The role requires a high level of technical expertise, independent decision-making, cross-functional leadership, and contribution to strategic R&D objectives, ensuring robust, scalable, and compliant pharmaceutical products..

As a Formulation & Process Development Scientist you will be responsible to:

• Evaluate product technical feasibility and strategic fit for development projects
• Independently conduct and/or oversee literature, patent, and regulatory research for RLDs, APIs, excipients, and manufacturing processes to support product development strategy.
• Design, develop, and optimize formulations and manufacturing processes using Quality by Design (QbD) principles, including:
  • API and excipient characterization
  • Risk assessments (e.g., DEC/FMEA)
  • Prototype development
  • Process parameter definition and optimization
• Execute feasibility, prototype, scale-up, and industrial-scale trials, ensuring processes are robust, reproducible, and commercially viable.
• Execute formulation and process changes (including API changes) for both new and existing R&D-developed products, ensuring regulatory compliance and minimal impact on product performance.
• Collaborate closely with Analytical Development, Stability Studies, Quality Assurance, Production, Regulatory Affairs, and Project Management to ensure aligned and timely project execution.
• Provide scientific input for the preparation, review, and approval of stability protocols, reports, and shelf-life assessments.
• Review and evaluate technical documentation and transferred-in formulations from external partners, ensuring robustness and successful integration into internal processes.
• Perform in-depth analysis of scale-up and manufacturing data to identify trends, risks, and opportunities for continuous improvement.
• Author and review high-quality technical documentation for development reports, technology transfer packages, regulatory submissions (CTDs), and responses to regulatory queries.
• Ensure full compliance with SOPs, GDP, cGMP, and internal quality systems throughout all development activities.
• Ensure strict adherence to health, safety, and environmental requirements, promoting a strong safety culture within the laboratory and production areas.
• Prepare and review CRFs, technical justifications, and internal/external reports as required.
• Evaluate latest amorphous solid dispersion technologies like Hot Melt Extrusion, Spray drying etc. as per product requirement
• Perform any other duties assigned by the Head of Formulation and Process Development for the product development 

What you will bring:

• Bachelor’s in chemical engineering, Chemistry and Pharmacy
• Master’s degree in pharmaceutical sciences preferred
• 7-10 years of experience in a relevant field
• Previous experience Oncology product development and experience in HME is preferable
• Excellent communication skills
• Problem solving and Critical thinking
• Very good spoken and written English required.
• Proficiency in Word, Excel D.O.E Software. Basic use of tools specific to the profession.