Senior Analytical Development Scientist

Tecnimede Group; Viseu; Presencial; EUR 60 000 - 85 000; Tempo integral

Resumo da oferta

Tecnimede Group is seeking a Senior Analytical Development Technician to provide analytical support for drug product R&D projects. You will develop, transfer, implement and validate fit-for-purpose analytical methods in line with international guidelines and regulatory expectations.

Responsibilities include designing development studies, supporting strategy across dosage forms, and contributing to regulatory submissions while ensuring GMP/data integrity.

Qualificações

• Advanced knowledge of analytical chemistry, laboratory concepts and techniques.
• Understanding of ICH, EMA and FDA expectations for analytical development and validation.
• Experience supporting pharmaceutical development activities and regulatory submissions.

Responsabilidades

• Develop, transfer, implement and validate fit-for-purpose analytical methods.
• Design and execute analytical development studies for drug substance and product.
• Support analytical strategies across sterile and non-sterile dosage forms.
• Provide analytical support to preclinical/clinical development and regulatory submissions.
• Analyze and communicate results to project teams and aid decision-making.
• Ensure data and documentation comply with GMP and data integrity standards.
• Contribute to continuous improvement and best practices within Analytical Development.

Conhecimentos

Analytical development

Analytical chemistry

Method development

Validation

Stability testing

Data integrity

Cross-functional teamwork

Formação académica

University degree in Chemistry, Pharmaceutical Sciences, Pharmacy or related scientific field

Descrição da oferta de emprego

Tecnimede Group is seeking a Senior Analytical Development Technician to provide analytical support for drug product R&D projects. You will develop, transfer, implement and validate fit-for-purpose analytical methods in line with international guidelines and regulatory expectations.

Responsibilities include designing development studies, supporting strategy across dosage forms, and contributing to regulatory submissions while ensuring GMP/data integrity.