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Title:  Team Leader - R&D

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.

 

The Team Leader – New Product Development & Submission will lead and guide the R&D team in developing new pharmaceutical products across multiple dosage forms. This includes solids, liquids, semi-solids, injectables, inhalers, and biosimilars. The role involves project planning, process optimization, regulatory submissions, and technology transfer while ensuring adherence to cGMP/GDP principles.

Key Responsibilities

  • Lead, guide, and plan the work of new and existing team members.

  • Conduct literature surveys, patent searches, and prepare Prototype Formulation Reports.

  • Identify the reference product and initiate procurement processes.

  • Develop the Quality Target Product Profile (QTPP) based on literature review and reference product characterization.

  • Identify and finalize API and excipient sources for new product development.

  • Perform and conclude pre-formulation/drug-excipient compatibility studies for assigned projects.

  • Participate in product process optimization, reformulation, and project closure, including report writing.

  • Prepare registration dossiers of products for submission to health authorities.

  • Plan, design, and perform pharmaceutical experiments using the QbD (Quality by Design) approach.

  • Review analytical development data and systematically compile product information.

  • Support manufacturing of batches for process optimization, submission, and bioequivalence (BE) studies.

  • Knowledge and application of Bioequivalence, Q1/Q2/Q3, IVRT, and IVPT studies.

  • Support manufacturing of pilot/scale-up batches with required documentation and execute technology transfer to production.

  • Prepare and maintain R&D SOPs in compliance with cGMP and GDP principles.

  • Prepare periodic project reports and submit updates to the Manager.

  • Collaborate effectively with Analytical R&D, Supply Chain, Production, Quality Control, Quality Assurance, Regulatory Affairs, and Medical Affairs teams to ensure timely project completion.

  • Handle eQMS activities related to projects.

Core Competencies

  • Strong results and process orientation for departmental achievement.

  • Analytical mindset with a structured and responsible approach.

  • Strong understanding and practice of cost consciousness.

  • High attention to detail, accountability, and ownership.

  • Excellent team-building, time management, and task management skills.

  • Strong oral and written communication skills in English.

  • Highly disciplined, motivated, and organized.

Qualifications / Functional Knowledge

Education:

  • Master’s degree in Pharmacy (preferred) or Bachelor’s degree in Pharmacy.

Experience:

  • Extensive experience (10+ years) in formulation development of pharmaceutical dosage forms for global markets.

  • Expert in QbD – Design Expert software application.

  • Expert in Minitab software application.

  • Significant exposure in addressing regulatory queries for US-FDA, EU, Canada, UAE, MENA, and KSA markets.

  • Proven experience handling diverse dosage forms, including injectables, in an R&D environment.

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

Apply now »