Job Ref. ID:
Senior Research Scientist 2
Research & Development - FND
UNITED ARAB EMIRATES
UAE (RAK head office)
Senior Research Scientists
Full Time Employment (Limited Contract)
The role of Senior Research Scientist 2 is responsible for formulation development of Generic Drug Formulations, trouble shooting of Existing Formulations for quality improvement and technology transfer of products & processes. He should maintain an accurate and complete laboratory records required by company policy and Good Manufacturing Practices (cGMP) requirements. Responsible for guiding team members in development & technical troubleshooting.
Key responsibilities & Accountability:
Performing literature survey, patent search and preparation of Prototype Formulation Report.
Identifying the reference product initiating the process for procurement of Reference Product. Developing Quality Target Product Profile based on knowledge gained from literature search and Reference Product characterization.
Identification and finalization of API and Excipient sources for new product development.
Responsible for performing and concluding pre-formulation/Drug-Excipient compatibility studies of assigned projects.
Participate in product process optimization, reformulation of the product- report writing and closing Prepare registration dossiers of products for submission, support CTD and dossiers documents Planning, designing and performing pharmaceutical experiments for the new product development by QbD approach
Review of analytical development data and systematic compilation of the assign product data. Supporting in the manufacturing of batches for process optimization, submission batches and BE studies.
Supporting manufacturing Of pilot/scale-up batches with necessary documentation and technology transfer of products and processes to production.
Prepare R & D relevant SOP's for GLP and GDP compliance.
Prepare periodic project report and submit it to Manager.
Collaborate with Analytical Research Development, Supply Chain, Production, Quality Control, Quality Assurance, Regulatory Affairs team and Medical Affairs team to complete projects on time.
• Master degree in Pharmacy or Science is preferred.
• At least 10+ year professional experience working in a reputed company in pharmaceutical industry
• Significant exposure in addressing regulator queries for US-FDA, EU, Canada Market
Excellent in Result and Process Orientation for department achievement, Responsible in approach with strong Analytical Skills.
Strong attention to details, high on accountability and ownership
Excellent team building, strong time and task management Excellent oral and written communication skills in English
Past experience of handling different dosage forms in R & D
-IR tablets, capsules
- ER tablets with Matrix, Dispersible and Osmotic drug delivery system
- Oral Solutions, Suspensions
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