At Julphar, we are on a journey of culture transformation & our mission is to provide a better quality of life for the entire family by delivering best in class solutions and real value with compassion and professionalism.
Our core values: Respect, Collaboration, innovation, Integrity and Compassion - Combined with a focus on diversity, inclusion, and equal opportunities - are key drivers in our aim to make a positive impact on the lives of the patients we serve, enable Talents , create a healthy work environment, and accomplish our goals through world-class research and with the compassion and commitment of our employees.
Key Responsibilities
- Conduct comprehensive literature reviews and patent searches, and prepare Prototype Formulation Reports.
- Identify reference products and initiate procurement processes.
- Develop Quality Target Product Profiles (QTPP) through in-depth literature research and reference product characterization.
- Finalize API and excipient sources for new product development.
- Conduct pre-formulation studies and drugexcipient compatibility assessments for assigned formulations.
- 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.
- Plan, design, and execute experiments using the Quality by Design (QbD) approach.
- Review analytical development data and systematically compile relevant formulation information.
- Support manufacturing of batches for process optimization, submission, and bioequivalence (BE) studies.
- Participate in pilot and scale-up batch manufacturing and facilitate technology transfer to production with appropriate documentation.
- Develop and maintain R&D SOPs in accordance with cGMP and GDP guidelines.
- Prepare and submit project progress reports to management on a periodic basis.
- Collaborate with cross-functional teams including 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 for assigned projects.
- Participate in packaging development activities, ensuring compatibility and regulatory compliance.
- Handle eQMS activities, ensuring timely documentation, closure of actions, and adherence to quality systems.
Core Competencies
- Strong result and process orientation to support departmental goals.
- High sense of ownership, accountability, and attention to detail.
- Proactive, cost-conscious approach in decision-making.
- Demonstrated ability in team leadership, effective task and time management.
- Excellent written and verbal communication in English.
- Highly organized, disciplined, and self-driven.
Education & Qualifications
- Master's Degree in Pharmacy or Bachelor's Degree with relevant formulation experience.
Experience Requirements
- 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 a wide range of dosage forms including solid, liquid, semi-solid, and injectable formulations.
We value people from different backgrounds. Could this be your story Apply today or visit www.Julphar.net to read more about us and the journey of Julphar
