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Pharmaceutical Development Project Leader

hace 2 semanas

Valencia, Valencia, España Bionanopharma A tiempo completo

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 transfer.


• Provide trouble shooting and optimization of formulations, process performance and technical performance in cooperation with the production department.


• Perform literature searches, extract relevant information from patents and scientific publications.


• Write protocols, reports, master batch records, technical transfer documents and other key documents as per ICH guidelines and regulatory requirements.


• Prepare product development reports, write and review quality overall summary and other documents to support CMC regulatory submissions for filing and answering to deficiency letters.


• Prepare the scientific documentation for quality and regulatory affairs to support the projects assigned and to meet the standard approval flow established by the quality system; all in accordance to GMP and CFR regulations, compliance with quality system and technical agreements and contracts with third parties so that projects progress properly.


• Review and interpret results from analytical characterization (TGA, DSC, SEM, vibrational spectroscopy, mechanical testing, rheology, release profiles, etc.) to elucidate structure–processing–property–function relationships critical to formulation optimization.


• Analyze the status of patents that affect products assigned and the results obtained in the clinical or preclinical studies.


• Prepare summary reports and presentations for review by management.


• Collaborate and interact closely with the analytical department and the manufacturing department.


• Ensure good relationships and collaboration with all other teams involved in the development, QA, Patents, Medical, Regulatory Affairs, etc.


• Ensure good relationships and efficient follow up and tracking of development activities outsourced to third party organizations.


• Advice on ways forward for development, deviations and modifications of the assigned pharmaceutical formulations, according to SOP's, the ICH, EMEA, FDA guidelines, in order to reach the final product, ensuring that all parameters match production planning, decide future action in product development and get the results at the set time.

Competencies/Career level

Leadership, innovation, customer orientation, communication, teamwork, adaptability/flexibility, productivity, self-development, sense of urgency, initiative.

Accountabilities

Those set up as individual objectives.

Requirements and personal skills


• Education: MSc or related scientific Degree in Pharmaceutical Sciences, Biology and Biochemistry. PhD in Pharmaceutical Sciences is a plus.


• Languages: Fluent in English, basic knowledge of Spanish, knowledge of other languages will be an asset.


• Experience (years/area): +5 years of experience in leading formulation R&D projects in the pharmaceutical sector. Clinical and regulatory affairs experience desirable. Experience in managing multiple projects and experience with FDA requirements desirable.


• Specific Knowledge:

knowledge of GMP regulations. FDA and In-depth understanding of biological molecules (peptides, proteins, monoclonal antibodies, enzymes, RNA, oligonucleotides) and their stabilization within polymeric or hybrid carriers such as Lipid Nanoparticles (LNPs) and Polymer–Lipid Nanoparticles (PLNs).

Familiarity with advanced formulation technologies, including electrospinning and electrospraying as enabling platforms for controlled released and biologic delivery is a big plus


• Travels: Open to travel.


• Personal skills: Impact and influence, good communication and project management skills, leadership.


• Other: Valid driver's license and own vehicle required.