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 drug–excipient 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
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