Sr. Research Scientist 2

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.

Roles And Responsibilities

• Conduct literature surveys, patent searches, and prepare Prototype Formulation Reports.
• Identify reference products and initiate procurement processes.
• Develop Quality Target Product Profiles (QTPP) based on literature insights and reference product characterization.
• Development of Injectable dosage forms; Biologics/Biosimilar products- upstream & downstream, for regulated markets.
• Identify and finalize API and excipient sources for new product development.
• Perform and conclude pre-formulation and drug–excipient compatibility studies for assigned projects.
• Contribute to product process optimization and reformulation activities, including report preparation and closure.
• Prepare registration dossiers for submission and support CTD/dossier documentation requirements.
• Plan, design, and execute pharmaceutical experiments using the QbD (Quality by Design) approach.
• Review analytical development data and systematically compile product-related data.
• Support manufacturing of batches for process optimization, submission, and bioequivalence (BE) studies.
• Assist in pilot and scale-up batch manufacturing, with necessary documentation, and facilitate technology transfer to production.
• Develop and maintain R&D-related SOPs in compliance with cGMP and GDP principles.
• Prepare and submit periodic project reports to management.
• Collaborate cross-functionally with Analytical R&D, Supply Chain, Production, QC, QA, Regulatory Affairs, and Medical Affairs to ensure timely project completion.
• Handle Technology Transfer out/Contract Manufacturing activities for assigned projects
• Experience in packaging development and life cycle management
  
  

Qualification/Functional Knowledge

Education: Master’s degree in Pharmacy/ Master’s degree in Biotechnology

Experience

• Minimum 8 years of extensive experience of working in Formulation Development of Injectable dosage forms; Biologics/Biosimilar products- upstream & downstream, for regulated markets.
• Significant exposure in addressing regulatory queries for US-FDA, EU, Canada, UAE, KSA and other stringent regulatory markets.
• Past experience of handling different dosage forms in R&D i.e. injectables, Biosimilars, Biologics etc.
  
  

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