Formulation Development Manager

About the role

Hikma Pharmaceuticals is seeking a Manager, Formulation Development to lead the creation of oral solid dosage forms and other suitable dosage forms from concept through commercialization. You will work within a collaborative environment that values innovation, caring, and teamwork, supporting the company’s mission to improve global access to high‑quality medicines.

Key responsibilities

• Lead formulation development activities for generic and brand products across regulated markets (USA, Europe, Canada, MENA, etc.) from feasibility to dossier filing and commercialization.
• Design and develop robust, scalable, and commercially viable formulations using scientific and risk‑based approaches, applying Quality by Design (QbD) principles.
• Manage resources to meet project objectives within defined time, cost, and quality parameters.
• Ensure SOPs, cGMP, and health & safety standards are developed, maintained, and effectively implemented.
• Oversee departmental performance, align scientific initiatives with organizational goals, and develop staff capabilities.
• Collaborate closely with Analytical Development, Regulatory Affairs, Quality, Manufacturing, Supply Chain, and Project Management teams.
• Lead technology transfer, execution of registration/submission batches, and provide regulatory support.
• Introduce innovative methods and solutions to address challenges and improve performance.

Required profile

• Strong technical expertise in QbD‑based product development for oral solid dosage forms.
• Proven experience in registration/submission batch execution, technology transfer, and regulatory support.
• Demonstrated ability to lead and develop high‑performing, cross‑functional teams.
• Capability to secure and manage resources, introduce innovative solutions, and ensure compliance with SOPs, cGMP, and H&S standards.
• Ability to operate independently within global networks and align efforts with strategic goals.

Required skills

• Quality by Design (QbD) methodology
• cGMP compliance
• SOP development and implementation
• Regulatory submission processes
• Technology transfer
• Oral solid dosage form development
• Risk‑based formulation design