Team Leader - Product LCM

• Lead, guide, and plan the work of team members, including new joiners.
• 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 and reformulation activities, including report writing and project closure.
• Prepare registration dossiers of products for submission to health authorities.
• Design and execute pharmaceutical experiments for new product development using the QbD approach.
• Review analytical development data and compile product-related information systematically.
• Support manufacturing of batches for process optimization, submission, and bioequivalence (BE) studies.
• Possess knowledge of Bioequivalence studies, Q1/Q2/Q3 equivalence, IVRT, and IVPT.
• Support manufacturing of pilot/scale-up batches, prepare necessary documentation, and execute technology transfer of products and processes to production.
• Draft and maintain R&D SOPs in compliance with cGMP and GDP principles.
• Prepare periodic project reports and present updates to the Manager.
• Collaborate effectively with Analytical R&D, Supply Chain, Production, Quality Control, Quality Assurance, Regulatory Affairs, and Medical Affairs to ensure timely project completion.
• Handle eQMS activities related to projects.

• Strong result orientation with a focus on process excellence and departmental achievements.
• Analytical mindset with a structured and responsible approach.
• Strong cost-consciousness with the ability to balance efficiency and quality.
• High attention to detail, accountability, and ownership.
• Excellent leadership, team-building, and time-management skills.
• Strong communication skills (oral and written) in English.
• Highly disciplined, motivated, and organized professional.

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

• 10+ years of extensive experience in formulation development of pharmaceutical dosage forms for global markets.
• Expert in using QbD - Design Expert and Minitab software applications.
• Significant exposure in addressing regulatory queries for US-FDA, EU, Canada, UAE, MENA, and KSA markets.
• Proven experience in handling diverse dosage forms, including injectables, in an R&D environment.

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