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 Analytical Development Scientist / Senior Scientist (Level depending on experience).
The Analytical Development Scientist 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 5-10 years of 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 relevant ICH, EMA and FDA expectations applicable to analytical development, method validation, stability testing, documentation and data integrity;
* Experience supporting pharmaceutical 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 work with 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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