Senior R&D Manager

Job Description

HR Bamboos connects exceptional professionals with reputable organizations across Iran and international markets.

We are 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

Key Responsibilities
•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.

What You Bring
•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.

Nice to have
•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.

If you’re looking for a dynamic environment where your ideas, perspective, and contributions can make a meaningful impact on both your professional growth and the organization’s success, we’d love to hear from you.

Apply now

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