Senior Analytical Development Scientist

Tecnimede Group; Torres Vedras; Presencial; EUR 30 000 - 45 000; 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 analytical tasks are completed within defined timeframes and in accordance with quality standards.

You will develop, transfer, validate fit-for-purpose analytical methods, design development studies, and support regulatory submissions. Strong data integrity and collaboration across teams are essential to succeed.

Qualificações

• University degree in Chemistry, Pharmaceutical Sciences, Pharmacy or related scientific field.
• Minimum 5-10 years of experience in an analytical pharmaceutical environment (senior level for more experienced candidates).
• Advanced knowledge of analytical chemistry, laboratory concepts and pharmaceutical analytical techniques.
• Knowledge of ICH, EMA and FDA expectations for analytical development, validation and data integrity.
• Experience supporting pharmaceutical development activities, including formulation, stability and regulatory submissions.

Responsabilidades

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

Conhecimentos

Analytical development

Method development

Data integrity

Regulatory knowledge

Scientific communication

Team collaboration

Formação académica

University degree in Chemistry

Pharmaceutical Sciences

Pharmacy

Related scientific field

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 analytical tasks are completed within defined timeframes and in accordance with quality standards.

You will develop, transfer, validate fit-for-purpose analytical methods, design development studies, and support regulatory submissions. Strong data integrity and collaboration across teams are essential to succeed.