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

Tecnimede Group; Torres Vedras; On-site; EUR 30,000 - 45,000; Full time

Job summary

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.

Qualifications

• 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.

Responsibilities

• 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.

Skills

Analytical development

Method development

Data integrity

Regulatory knowledge

Scientific communication

Team collaboration

Education

University degree in Chemistry

Pharmaceutical Sciences

Pharmacy

Related scientific field

Job description

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 5-10 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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