Sr. Research Scientist 2
Julphar View all jobs
- Ras al-Khaimah
- Permanent
- Full-time
- Conduct 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
- Minimum 8 years of extensive experience of working in Formulation Development of Injectable dosage forms; Biologics/Biosimilar products- upstream & downstream, for regulated markets.
- Significant exposure in addressing regulatory queries for US-FDA, EU, Canada, UAE, KSA and other stringent regulatory markets.
- Past experience of handling different dosage forms in R&D i.e. injectables, Biosimilars, Biologics etc.