Senior Analytical Development Technician (M/F) - Pharmaceutical Development

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 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 to reinforce our team with a Senior Analytical Development Technician.

The Senior Analytical Development Technician will provide analytical support to drug product R&D projects guaranteeing that analytical tasks are accomplished within the time frame defined and according to company ́s quality standards.

You will be responsible for:

• Develop, transfer, implement and validate fit-for-purpose analytical methods in accordance with international guidelines, project needs and applicable regulatory expectations;
• Design and execute analytical development studies to generate knowledge on drug substance and drug product, supporting formulation development, process development, stability, comparability, technology transfer and regulatory submissions;
• Support analytical strategies for small molecules and biologics across sterile and non-sterile dosage forms, including complex products and drug-device combination products;
• Provide analytical support to preclinical and clinical development activities, regulatory submissions and CMC decision-making, where applicable;
• Analyze, interpret and communicate analytical results to project teams, contributing to scientific discussion, risk assessment, troubleshooting and decision-making;
• Ensure analytical data and documentation are properly managed according to internal procedures, GMP/data integrity principles and applicable regulatory expectations;
• Contribute to continuous improvement, knowledge sharing and implementation of best practices within the Analytical Development area.

Profile:

• University degree in Chemistry, Pharmaceutical Sciences, Pharmacy or related scientific field;
• Minimum of 5-10yearsof experience in an analytical pharmaceutical environment (more experienced candidates to be consider for Senior Scientist level) - Advanced knowledge of analytical chemistry, laboratory concepts and pharmaceutical analytical techniques, including method development, transfer, validation, troubleshooting and stability-indicating methods;
• Knowledge of relevantICH, EMA and FDA expectations applicable to analytical development, method validation, stability testing, documentation and data integrity;
• Experience supportingpharmaceutical development activities, including formulation, process development, stability, comparability, preclinical/clinical development and/or regulatory submissions, is valued;
• Exposure to complex dosage forms, complex generics, value-added medicines, sterile/injectable products, peptides/biologics, ophthalmic or nasal products is considered an advantage;
• Ability to workwith autonomy across multiple projects and/or tasks, with good scientific judgement, attention to detail and clear communication skills;
• Growth mindset,positive attitude, team spirit, sense of responsibility and motivation for continuous improvement;
• Comfortable working in a results-driven and fast-paced pharmaceutical development environment;
• Proficiency in English and Portuguese.

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