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 safe 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
