Key Accountabilities

· Translate the target product profile, reference-product understanding and regulatory requirements into a practical development plan with clear experiments, risks, deliverables and decision points.

· Execute pre-formulation, prototype development, optimisation, process studies and scale-up activities using sound pharmaceutical science, QbD and risk-management principles.

· Generate complete, contemporaneous, attributable and scientifically interpretable records in accordance with approved procedures and ALCOA+ data-integrity expectations.

· Investigate unexpected results, deviations, atypical observations and development failures using evidence-based root-cause analysis; recommend technically defensible corrective actions.

· Coordinate formulation activities with analytical, packaging, quality, regulatory, clinical/BE, project-management and manufacturing teams to achieve integrated project milestones.

· Prepare and review development protocols, laboratory records,



reports, product-development summaries, risk assessments, technology-transfer documents and CMC submission inputs.

· Support exhibit/registration batches, process validation readiness, site transfer, troubleshooting and commercialisation activities as assigned.

· Protect customer confidentiality, Axxelent intellectual property, controlled documents, samples, data and electronic records.

· Coach junior team members in secure laboratory practices, documentation discipline, experimental execution and scientific reasoning without assuming formal supervisory authority unless assigned.

· Contribute to laboratory readiness, equipment use, material control, EHS compliance, productivity improvement and knowledge reuse.

Pay: ₹400,000.00 - ₹1,000,000.00 per year

Work Location: In person

📌 Formulation Development (India)
🏢 Axxelent Pharma Science
📍 India