Pharmaceutical Development Project Leader - Spray Drying

Position: Pharmaceutical Development Project Leader - Spray Drying

Company: Bionanopharma

Location: Valencia

Want to know more? 👇

At Bionanopharma, we are looking for a Pharmaceutical Development Project Leader - Spray Drying to lead key pharmaceutical formulation projects within the R&D department, ensuring their technical, regulatory, and operational progress.

The selected person will be responsible for planning, coordinating, and supervising the pharmaceutical and analytical development activities of assigned projects, ensuring that the developed products and processes are robust, scalable, and aligned with quality, safety, and regulatory compliance standards.

What are we looking for? 🔎

We are looking for a profile with solid technical experience and leadership capacity to undertake, among others, the following responsibilities:

• Lead assigned pharmaceutical formulation projects within the R&D department.
• Plan, organize, coordinate, and supervise the pharmaceutical and analytical development activities of the projects.
• Track project progress and report its evolution to the R&D Manager, other departments, and clients.
• Design, direct, and/or supervise preformulation, compatibility, formulation development, process development, optimization, and scale-up studies.
• Define the most suitable formulation and process development strategy for each project.
• Closely coordinate analytical activities together with the analytical development team.
• Evaluate experimental results and monitor the work of the scientific team to ensure robust formulations and processes.
• Ensure that the developed products and processes are suitable for successful transfer and scale-up to commercial manufacturing.
• Interact with raw material suppliers to select the appropriate quality of APIs, excipients, and closure/packaging systems.
• Analyze the status of patents affecting products under development and review the results of bioequivalence studies.
• Supervise batches for bioequivalence or registration, as well as reports, technical documentation, and personnel involved in development.
• Advise and report on the path to follow in the development, deviations, and modifications of solid pharmaceutical dosage forms.
• Draft and/or review protocols, reports, master batch records, technical transfer documentation, and other critical documents.
• Prepare product development reports, Quality Overall Summary, and CMC documentation for regulatory submissions and responses to deficiency letters.
• Guarantee compliance with GMP, CFR, SOPs, ICH, EMEA, and FDA guidelines, as well as the quality system, technical agreements, and contracts with third parties.
• Ensure smooth collaboration with areas such as QA, Patents, Medical, Regulatory Affairs, HSE, Manufacturing, and other involved areas.

This position may not fit you now, but perhaps it will next time.

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