Empresa:

Tecnimede Group

Descrição da Função

Tecnimede Group is a 40 years Portuguese multinational company that wants to improve and preserve human life and health through the development, production and marketing of pharmaceutical products with a strong focus on quality and technological innovation. The group covers the entire life cycle of the medicinal products for human use with a strong investment in research and development.

We are looking for a Translational Biopharmaceutics Scientist to support the scientific translation of pharmaceutical design into predicted in vivo performance. This position sits within Pharmaceutical Development and will focus on building mechanistic understanding across in vitro, in vivo, and in silico data to inform development strategy. The role will work closely with Clinical, Regulatory, and CMC teams to ensure scientific alignment, without direct responsibility for clinical trial execution or operations.

Key Responsibilities

Translational & IVIVC Strategy

• Develop IVIVC/IVIVR frameworks linking formulation attributes to in vivo behavior
• Define clinically relevant dissolution and release methodologies
• Integrate CQAs with biopharmaceutic and pharmacokinetic rationale
• Contribute to PBPK and predictive modeling strategies

Preclinical & In Vivo Scientific Support

• Design, review and support pre-clinical in vivo study protocols
• Interpret in vitro and in vivo datasets to guide formulation and dose rationale
• Support translation of key findings into human exposure expectations

Advanced & Complex Therapies

• Provide scientific input into protocol concepts for early human studies, including cell gene therapies
• Support dose justification and risk assessment from a CMC and translational science perspective
• Ensure CMC attributes are mechanistically aligned with anticipated clinical performance
• Contribute scientific sections to regulatory documentation

Who are we looking for

• Advanced degree (MSc or PhD) in Pharmaceutical Sciences, Biopharmaceutics, Pharmacokinetics, Biomedical Sciences, or related discipline
• Strong understanding of IVIVC, PK/PD principles, and translational science
• Experience in pre-clinical in vivo study design and results interpretation
• Exposure to PBPK or similar modeling tools is valued
• Knowledge or experience in complex dosage forms (e.g., long-acting injectables, modified-release systems, peptide formulations), biologics, or advanced therapies (cell and gene therapy) is considered an advantage
• Ability to integrate multidisciplinary data into coherent development strategy

Why This Role Matters

Tecnimede is reinforcing its innovative drug product development platform, with a focus on complex formulations, long-acting injectables, peptides, and advanced therapeutic modalities. As our portfolio evolves, we are strengthening the scientific integration between pharmaceutical technology, preclinical performance, and expected human outcomes.

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Observações

Lisboa (Portugal)