Back to jobsConduct literature surveys, patent searches, and prepare Prototype Formulation Reports.
Identify reference products and initiate procurement processes.
Develop Quality Target Product Profiles (QTPP) based on literature insights and reference product characterization.
Development of Injectable dosage forms; Biologics/Biosimilar products- upstream & downstream, for regulated markets.
Identify and finalize API and excipient sources for new product development.
Perform and conclude pre-formulation and drug–excipient compatibility studies for assigned projects.
Contribute to product process optimization and reformulation activities, including report preparation and closure.
Prepare registration dossiers for submission and support CTD/dossier documentation requirements.
Plan, design, and execute pharmaceutical experiments using the QbD (Quality by Design) approach.
Review analytical development data and systematically compile product-related data.
Support manufacturing of batches for process optimization, submission, and bioequivalence (BE) studies.
Assist in pilot and scale-up batch manufacturing, with necessary documentation, and facilitate technology transfer to production.
Develop and maintain R&D-related SOPs in compliance with cGMP and GDP principles.
Prepare and submit periodic project reports to management.
Collaborate cross-functionally with Analytical R&D, Supply Chain, Production, QC, QA, Regulatory Affairs, and Medical Affairs to ensure timely project completion.
Handle Technology Transfer out/Contract Manufacturing activities for assigned projects
Experience in packaging development and life cycle management