ADL

Preparation of literature search reports and patent infringement analysis of the formulation strategies received from FnD team and third party APIs for different geographies.

Development of simple and complex parenteral & ophthalmic formulations - Generic & 505(B)(2), Conduct literature research and evaluate new technologies / excipients.

Routine Analysis and Analytical Method Development for various products like solid orals, injectable, semi-solids, liquids and Active Pharmaceutical Ingredients.

Experience in HPLC, GC, Dissolution, UV, TOC, and Sterility Testing. Hands-on expertise in analytical method development and validation. Aculife Healthcare

Method development & validation for tablets, capsules, creams & ointments. Exposure to US/EU regulatory requirements.

M.Sc/ B.Pharm / M.Pharm. To plan, prepare and review of high quality dossier with support and guidance, assuring technical concurrency and regulatory compliance, meeting agreed upon timeline.

M.Pharm. Exposure in EU/ US/ UK/ ROW market. Formulation patent exposure. Strong communication skills, Problem-Solving, & Adaptability.

Solid Oral Formulation Development, QbD, Scale-Up, Pilot Batches & Tech Transfer. Literature Review & Excipient Compatibility.

The candidate should competent and motivated in Production (OSD) with sound experience in Oral Solid Dosage manufacturing processes.