Senior R&D Manager

HR Bamboos is seeking a Senior R&D Manager on behalf of an established pharmaceutical company. The role focuses on leading new product development, optimizing existing formulations, and transferring products from development to commercial-scale manufacturing. We are looking for a strategic, results-oriented leader with strong change management skills to drive the company's R&D initiatives.

• Develop R&D strategies and execution plans aligned with the company's objectives and product portfolio priorities.
• Contribute to new product selection by evaluating technical feasibility, resource requirements, and development costs.
• Lead the design and development of new product formulations and the revision of existing formulations and manufacturing processes.
• Oversee product development from laboratory and pilot-scale batches through scale-up and technology transfer to manufacturing lines.
• Lead the preparation and review of R&D documentation and relevant sections of the Common Technical Document (CTD) for submission to the Regulatory Affairs team.
• Direct the investigation of manufacturing issues and develop corrective solutions for formulation and manufacturing process challenges.
• Plan and manage budgets, equipment, and raw materials required for R&D projects.
• Lead and develop the R&D team by setting objectives, evaluating performance, and transferring technical knowledge to team members.

• Doctor of Pharmacy (Pharm.D.)
• At least 10 years of relevant experience in the pharmaceutical industry, including experience managing R&D teams and projects.
• Strong expertise in pharmaceutical dosage form formulation, product development, and drug manufacturing processes.
• Hands-on experience in scale-up, technology transfer, and troubleshooting manufacturing issues.
• Strong knowledge of bioequivalence studies and the Biopharmaceutics Classification System (BCS).
• Expertise in preparing and reviewing CTD documentation and understanding regulatory requirements related to pharmaceutical product development and registration.
• Strong knowledge of Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), pharmacopeial standards, and quality management system requirements.
• Practical knowledge of ICH guidelines for pharmaceutical development and quality risk management.
• Experience assessing and managing quality risks using approaches such as Quality Risk Management (QRM) and Failure Mode and Effects Analysis (FMEA).
• Strong project management and prioritization skills, including managing multiple projects, allocating resources, and making decisions based on scientific and technical data.
• Proven leadership and team development skills, with experience coordinating effectively across different organizational functions.

• Experience developing novel drug delivery systems.
• Experience applying Quality by Design (QbD) principles to product development and manufacturing processes.
• Previous research collaboration with universities and research institutions on drug development projects.