Senior Analytical Scientist
il y a 2 semaines
MedinCell is a pharmaceutical company at commercial stage that develops innovative long-acting injectable medicines in various therapeutic areas based on its proprietary BEPO technology.
We are seeking a highly skilled Senior Analytical Scientist to join our Analytical Development & Testing team, based in Montpellier.
As Senior Analytical Scientist, you will be responsible for the development (design of experiments, data generation and interpretation), pre-validation, and implementation of analytical methods using UPLC/HPLC systems to support our development projects.
Your mission at MedinCell
Key Responsibilities- Method Development: Design and perform quality scientific experiments to develop robust analytical chromatographic methods. Implement risk assessment and Quality-by-Design (QbD) concepts during analytical method development whenever possible. Make sound scientific conclusions and decisions.
- Experiment Coordination: Coordinate and ensure successful timely completion of experiments alone or with the support of team members.
- Method Implementation: Perform and document chromatographic method development, method check/pre-validation and transfer within the appropriate quality framework in adherence with company quality management system and ICH guidelines.
- Data Analysis: Compile, analyze and interpret data to achieve a robust and fit-for-purpose chromatographic methods. Present to the team during technical meetings.
- SOP Development: Write/update or review SOPs related to equipment use and analytical methods.
- Interdepartmental Collaboration: If required or necessary, interact with other departments for supporting activities such as project managers, R&D team, regulatory affairs, process development, transfer team and CDMOs.
- Communication: Participate in client meetings and/or teleconferences when required, communicating in English.
- Method Transfer: Support the subsequent transfer of chromatographic test methods to both internal and external (CDMO) end users.
- Continuous Improvement: Support continuous improvement efforts in lab procedures, develop best practices and ensure compliance with the Quality Management System.
- Technology Evaluation: Identify and evaluate new analytical technologies. Expand existing analytical capabilities.
- MSc in Analytical Chemistry or Chemistry or any relevant field with at least 5 years' relevant experience in HPLC/UPLC method development and pre-validation in an R&D environment.
- Confident Empower3 software user.
- Experience in DoE (Use of S-Matrix Fusion Qbd software or equivalent) would be an advantage.
- Knowledge of QbD principles in relation to analytical method development and pre-validation would be an advantage.
- Knowledge and interest in other analytical techniques, in particular MS, a plus.
- Experience in the pharmaceutical industry working under GMP/GLP and ICH Guidelines is a plus.
- Strong analytical background, scientifically curious and open to other analytical techniques.
- Good knowledge/experience of analytical instrumentation.
- Knowledge of basic statistics and experimental design.
- Excellent decision-making and technical problem-solving skills.
- Excellent planning and organizational skills.
- Good oral and written communication in both English and French.
- Experience in writing scientific documents in English preferred.
- Experience working in an international team or with international clients preferred.
- Transnational/international educational or work experience a plus.
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