Senior Analytical Development Specialist

Tecnimede Group; Torres Vedras; Presencial; EUR 42 000 - 66 000; Tempo integral

Resumo da oferta

Tecnimede Group in Portugal seeks a Senior Analytical Development Technician to provide analytical support to drug product R&D projects, ensuring tasks are completed on time and to quality standards.

You will develop, transfer, implement methods, and support regulatory submissions across sterile and non-sterile dosage forms, contributing to continuous improvement within Analytical Development.

Qualificações

• University degree in a chemical/ pharmaceutical science field.
• 5–10 years of experience in analytical pharmaceutical environments.
• Knowledge of ICH/EMA/FDA expectations for analytical development, method validation, stability and data integrity.
• Experience supporting pharmaceutical development activities across dosage forms and regulatory submissions.

Responsabilidades

• Develop, transfer, implement and validate fit-for-purpose analytical methods per guidelines and regulatory expectations.
• Design and execute development studies to support formulation, process development, stability and regulatory submissions.
• Support strategies for small molecules and biologics across dosage forms, including complex products.
• Provide analytical support to preclinical/clinical development activities and CMC decisions.
• Analyze, interpret and communicate analytical results to project teams and management.
• Ensure data and documentation are properly managed per GMP and data integrity principles.
• Contribute to continuous improvement and knowledge sharing in Analytical Development.

Conhecimentos

Analytical chemistry

English

Portuguese

Autonomy

Formação académica

University degree in Chemistry/Pharmaceutical Sciences

Descrição da oferta de emprego

Tecnimede Group in Portugal seeks a Senior Analytical Development Technician to provide analytical support to drug product R&D projects, ensuring tasks are completed on time and to quality standards.

You will develop, transfer, implement methods, and support regulatory submissions across sterile and non-sterile dosage forms, contributing to continuous improvement within Analytical Development.