Analytical Scientist
Il y a 3 mois
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 an Analytical Scientist, experienced in physico-chemical techniques (e.g., PSD, Rheology, DSC) to join our Analytical Development & Testing team, based in Montpellier
As Analytical Scientist, you will be responsible for the development (design of experiments, data generation and interpretation), method check and pre-validation, and implementation of analytical methods (testing) used to support our development projects.
Your mission at MedinCell
As Analytical Scientist experienced in physico-chemical techniques, you will be responsible for equipment under your responsibility (Morphology G3, MS3000, Rheometer, Differential Scanning Calorimetry, Gel Permeation Chromatography, FT-IR, Titrator method Karl Fisher) included the following missions:
- the periodic performance and suitability check of equipment.
- troubleshooting and preventive maintenance on the equipment.
- review SOPs related to equipment use and analytical methods.
- evaluate new analytical technologies.
As Analytical Scientist, you will also be responsible for development, method check/pre-validation, testing and transfer of analytical method on equipment under your responsibility and expertise included the following missions:
- literature survey to define design space of the method development.
- the Analytical Target Profile and protocol of each method development mission.
- execute method development to develop robust analytical methods.
- compile, analyze and process raw data to achieve a robust and fit-for-purpose methods.
- write protocol and execute method in accordance with internal and ICH guidelines.
- perform & document method development, method check / pre-validation.
- support transfer of test methods to internal and external (CDMO) end users.
- implement analytical method performing all testing for internal or external requests.
Your profile
Requirements
- Bachelor with at least 10 years relevant experience with 5 years pharmaceutical experience or MSc in Analytical Chemistry with at least 3 years relevant experience in a pharmaceutical development department in at least two of the following analytical techniques: Particle Size Determination by Laser diffraction or Optical Microscopy, Rheology or DSC techniques.
- Experience in the use of Morphologi G3, Mastersizer 3000, Lab X, and Empower 3 software is a plus.
- Experience in the use of Gel Permeation Chromatography, KF, FT-IR is a plus.
- Knowledge of QbD principles in relation to analytical method development and pre-validation would be an advantage.
- Experience in the pharmaceutical industry working under GMP/GLP and ICH Guidelines is a plus.
Soft-Skills
- Excellent decision-making and technical problem-solving skills
- Excellent planning and organizational skills
- Good oral and written communication in both English and French
- Team spirit, autonomous, analytically minded, rigorous, methodical, perseverant
- Effective functioning in a rapidly changing environment and adherence to the values, principles and mission of the company
- Desire to continuously improve and progress
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