Julphar
Senior Research Scientist 2
- Permanent
- Ras Al Khaimah, United Arab Emirates
- Experience 5 - 10 yrs
Job expiry date: 05/12/2025
Job overview
Date posted
21/10/2025
Location
Ras Al Khaimah, United Arab Emirates
Salary
Undisclosed
Compensation
Job description
The Sr. Research Scientist 2 role at Julphar leads end-to-end formulation development for regulated markets by conducting comprehensive literature reviews and patent searches; preparing Prototype Formulation Reports; identifying reference products and initiating procurement; developing Quality Target Product Profiles (QTPP) via in-depth literature research and reference product characterization; finalizing API and excipient sources for new product development; performing pre-formulation studies and drugâexcipient compatibility assessments; contributing to formulation optimization and reformulation with timely reporting and project closure; assisting in registration dossiers and supporting CTD/dossier documentation for regulatory submissions; planning, designing, and executing experiments using the Quality by Design (QbD) approach; reviewing analytical development data and compiling formulation information; supporting manufacturing of batches for process optimization, submission, and bioequivalence (BE) studies; participating in pilot and scale-up batch manufacturing and facilitating technology transfer to production with appropriate documentation; developing and maintaining R&D SOPs in accordance with cGMP and GDP; preparing and submitting periodic project progress reports; collaborating with Analytical R&D, Supply Chain, Production, QC, QA, Regulatory Affairs, and Medical Affairs to ensure timely project delivery; overseeing technology transfer and contract manufacturing activities; participating in packaging development to ensure compatibility and regulatory compliance; and handling eQMS activities with timely documentation, closure of actions, and adherence to quality systems across solid, liquid, semi-solid, and injectable dosage forms for regulated markets including US-FDA, EU, Canada, UAE, Jordan, and KSA.
Required skills
Key responsibilities
- Conduct comprehensive literature reviews and patent searches and prepare Prototype Formulation Reports for assigned products.
- Identify reference products, initiate procurement processes, and characterize references to inform Quality Target Product Profile (QTPP) development.
- Develop QTPP through in-depth literature research and reference product characterization, and finalize API and excipient sources for new product development.
- Perform pre-formulation studies and drugâexcipient compatibility assessments to de-risk formulation pathways.
- Plan, design, and execute experiments using a Quality by Design (QbD) approach and compile systematic formulation documentation.
- Contribute to formulation optimization and reformulation activities; prepare reports and ensure timely project closure.
- Assist in the preparation of registration dossiers and support CTD/dossier documentation for regulatory submissions.
- Review analytical development data and integrate findings into formulation strategy and reports.
- Support manufacturing of process optimization, submission, and bioequivalence (BE) batches in collaboration with cross-functional teams.
- Participate in pilot and scale-up batch manufacturing and facilitate technology transfer to production with complete documentation.
- Develop and maintain R&D SOPs compliant with cGMP and GDP and ensure adherence to quality systems, including eQMS activities and timely action closures.
- Prepare and submit periodic project progress reports to management and stakeholders.
- Collaborate with Analytical R&D, Supply Chain, Production, QC, QA, Regulatory Affairs, and Medical Affairs to ensure timely project delivery.
- Oversee technology transfer and contract manufacturing activities and participate in packaging development ensuring compatibility and regulatory compliance.
Experience & skills
- Masterâs Degree in Pharmacy or Bachelorâs Degree with relevant formulation experience.
- Minimum 8 years of extensive experience in formulation development for regulated markets.
- Proven expertise in handling regulatory queries for US-FDA, EU, Canada, UAE, Jordan, and KSA.
- Practical experience with solid, liquid, semi-solid, and injectable dosage forms.
- Demonstrated ability to plan, design, and execute QbD-based experiments and compile CTD/dossier documentation.
- Experience supporting pilot, scale-up, process optimization, submission, and BE batches with successful technology transfer to production.
- Proficiency with cGMP, GDP, eQMS, SOP development, and cross-functional collaboration (Analytical R&D, Supply Chain, Production, QC, QA, Regulatory, Medical Affairs).
- Excellent written and verbal English communication, strong ownership, attention to detail, and effective task/time management with a proactive, cost-conscious approach.
