Company: Bionanopharma
Reporting to: CSO
Vacancy Location: Paterna (Valencia, Spain)
Global Responsibility:
Lead the assigned pharmaceutical formulation projects within the R&D department, planning, coordinating and supervising the activities of the projects assigned and report their progress to the R&D Manager, other departments and customers.
Be responsible for formulation and process development activities associated with the pharmaceutical projects assigned. Also closely coordinate their corresponding analytical activities together with the analytical department.
Develop the required document formulation and process development strategies for polymeric, biopolymeric, and hybrid drug delivery systems, particularly long-acting injectables (LAIs) and other controlled-release platforms.
Analyze the status of patents that affect products under development and the results obtained in the clinical studies;
coordinate, schedule, monitor, review and validate the proper sequence of the pharmaceutical development plan, batches for bioequivalence or clinical development and registration, reports and people involved, deciding, advising and reporting on the way forward in the development, deviations and modifications of pharmaceutical forms, according to SOP's, the ICH, EMEA and FDA guidance.
Critically interpret analytical, preclinical, and clinical data to support development narratives, product characterization summaries, and manufacturing control justifications within the regulatory framework.
Provide scientific rationale for biomaterial selection, formulation design, process parameters, and stability testing strategies in accordance with CMC principles.
Ensure that the products and processes developed are suitable for a successful scale-up to commercial manufacturing. Interact with raw material vendors to select the suitable quality for API, excipients and container closure systems to be used for development and manufacturing.
Specific Responsibilities:
- Plan, organize and coordinate the activities of pharmaceutical and analytical development to ensure the proper progress of the projects assigned. Assess and monitor activities of formulation technicians, analyzing and evaluating the results, to develop robust formulations and processes.
- Design, direct and/or follow pre-formulation (compatibility studies), formulation development, process development, process optimization / scale-up on assigned projects.
- Design and oversee the development of polymeric and biopolymeric formulations, ensuring reproducibility, scalability, and compliance with regulatory and industry standards.
- Coordinate laboratory-scale process optimization (e.G., electrospinning, electrospraying, emulsification), emphasizing data integrity and regulatory relevance for dossier inclusion or technology