Senior Analytical Scientist
il y a 4 jours
MedinCell® is a pharmaceutical company at commercial stage that develops innovative long-acting injectable medicines in many therapeutic areas based on our BEPO® technology.
We are looking for a 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
- 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
- Coordinate and ensure successful timely completion of experiments alone or with the support of team members
- Perform & 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
- Compile, analyze and interpret data to achieve a robust and fit-for-purpose chromatographic methods. Present to the team during technical meetings
- Write/update or review SOPs related to equipment use and analytical methods
- 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
- Participate in client meetings and / or teleconferences when required, communicating in English
- Support the subsequent transfer of chromatographic test methods to both internal and external (CDMO) end users
- Support continuous improvement efforts in lab procedures, develop best practices and ensure compliance with the Quality Management System
- Identify and evaluate new analytical technologies. Expand existing analytical capabilities
Requirements
- 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 & 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.
Knowledge, skills and abilities
- 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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