Research and Development (R&D) Manager

Job TitleResearch and Development (R&D) ManagerDepartmentResearch & Development (R&D)Company: Alalamyah Pharma Ind.Location:Iraq - Baghdad -AltajiJob PurposeThe R&D Manager is responsible for leading and overseeing the research and development activities related to pharmaceutical products — including sterile and non-sterile formulations. This role ensures that all product development, formulation, and technology transfer projects comply with regulatory requirements, Good Manufacturing Practice (GMP), and company quality standards. The R&D Manager drives innovation and continuous improvement in formulations and processes to support the company’s growth and competitiveness.Key ResponsibilitiesLead and manage all R&D activities related to sterile (injectable, ophthalmic, and parenteral) and non-sterile dosage forms (solid, liquid, semi-solid).Design, plan, and oversee new product development projects from concept to commercial manufacturing.Ensure all formulation and process development follow GMP, GLP, and regulatory guidelines.Supervise sterile formulation development, aseptic process simulation, and technology transfer to production.Oversee development and optimization of manufacturing processes, including scale-up and validation.Evaluate and select appropriate APIs, excipients, and packaging materials for both sterile and non-sterile formulations.Manage stability studies and interpret results to ensure product quality throughout its shelf life.Collaborate with Quality Assurance, Production, and Regulatory Affairs to ensure compliance and successful product registration.Review and approve R&D reports, batch records, validation protocols, and technical documentation.Stay updated on new technologies, regulatory changes, and formulation trends, especially in sterile manufacturing.Train, mentor, and evaluate R&D staff to ensure technical excellence and adherence to company procedures.Maintain strict confidentiality of formulas, processes, and technical data.Qualifications And RequirementsBachelor’s degree in Pharmacy, Pharmaceutical Sciences, Chemistry, or Chemical Engineering (Master’s degree preferred).Minimum 14 years of experience in pharmaceutical R&D, including at least 5 years in sterile formulation development and 3 years in a managerial role.In-depth knowledge of GMP, GLP, ICH, WHO, and local regulatory guidelines.Proven experience in the development of sterile injectable and ophthalmic formulations.Strong understanding of aseptic processing, sterilization techniques, and cleanroom operations.Excellent leadership, planning, and project management skills.Strong communication, analytical, and report-writing abilities in English.Key CompetenciesStrategic planning and technical innovationExpertise in sterile and non-sterile formulationDecision-making and accountabilityTeam leadership and staff developmentCross-functional collaboration and communicationAttention to detail and regulatory compliance