About this role
HIPRA is a pharmaceutical and biotechnological company focused on prevention and diagnosis for animal and human health, with a broad range of highly innovative vaccines and an advanced diagnostic service.
HIPRA has a solid international presence in more than 40 countries, with its own subsidiaries, 11 diagnostic centres and 6 production plants strategically located in Europe (Spain) and America (Brazil).
Research and Development constitute the core of its knowledge. HIPRA dedicates 15% of its annual turnover to R&D activities that concentrate on the creation and application of the latest scientific advances to the development of the highest quality innovative vaccines. To give added value to its vaccination experience, the company also develops medical devices and traceability services.
The R&D Department at our HIPRA Campus in Aiguaviva (Girona) is actively seeking a highly skilled and driven R&D Researcher to join the Analytical Method Team for Human Health .
The successful candidate will be responsible for the development, optimization and qualification of analytical methods for recombinant proteins and biological products, with a strong focus on biochemical assays and molecular biology techniques . In a CDMO environment, he/she will also support analytical method transfers from clients to internal laboratories.
The role will also involve developing analytical strategies and methodologies for the characterization of Seed Lot Systems (SLS) and Cell Banks, including genetic identity, insert integrity, gene copy number determination and genetic stability assessments.
We are looking for candidates with:
- PhD in Biochemistry, Biotechnology, Molecular Biology, Biological Sciences or a related scientific discipline, or equivalent relevant industrial experience in biopharmaceutical analytical development.
- Strong hands-on experience in biochemical analytical techniques, particularly ELISA development and optimization, including assay design, data interpretation and troubleshooting.
- Solid knowledge and practical experience in molecular biology techniques, particularly PCR, qPCR, nucleic acid extraction and DNA analysis.
- Experience in analytical method development, optimization, qualification and/or validation within an academic or industrial research environment .
- Experience in genetic characterization of Seed Lot Systems and Cell Banks and familiarity with advanced molecular biology techniques such as digital PCR and NGS is desirable.
- Experience in the biopharmaceutical industry, including CMC analytical development according to ICH Q2, ICH Q14 and previous experience working in a CDMO environment is a plus .
- Demonstrated ability to independently design experimental strategies, interpret complex analytical data and propose scientifically sound solutions.
- Excellent verbal and written communication skills , including the preparation of clear scientific and technical documentation.
- Ability to work effectively in collaborative, multidisciplinary and client-facing environments.
- Demonstrated ability to design and execute analytical studies independently and translate findings into actionable conclusions.
- Proficiency level of spoken and written English for daily task development
At Hipra you will find:
- Continuous learning.
- A rapidly expanding multinational company.
- A multicultural environment open to new ideas.
Main Responsibilities
- Support the development of robust analytical methodologies to assess critical quality attributes (CQAs), ensuring method suitability, reproducibility and alignment with product development requirements.
- Lead or contribute to analytical method transfers from client organizations to internal laboratories, including method review, gap assessments, experimental execution, data analysis and preparation of transfer documentation.
- Apply Analytical Quality by Design principles, in alignment with ICH Q14, to the development and optimization of analytical methods.
- Develop and optimize ELISA-based assays for protein quantification, antigen characterization, binding activity and potency assessment, as well as other biochemical analytical techniques.
- Develop and implement molecular biology methods, including conventional PCR, qPCR and other DNA-based analytical techniques for product and biological starting material characterization.
- Contribute to analytical characterization strategies for Seed Lot Systems and Cell Banks (MCB, WCB, etc.).
- Contribute to the continuous improvement of analytical platforms, identifying opportunities for new technologies, methodological improvements and laboratory efficiency.
- Ensure compliance with applicable GxP principles, company quality standards and relevant regulatory guidelines.
HIPRA offers equal opportunity to all of its employees.
All qualified applicants will be considered for the position to be filled, without regard to gender, race, nationality, disability or age.
All hiring decisions are made on the basis of merit, competence and the needs of the company.