As Associate Scientist of the Structure, Spectro & Generic testing platform in Analytical R&D (ARD), you will plan & execute lab activities in a team in charge of release and characterization of vaccines candidates (antigens / adjuvant systems) using :
Spectrophotometric techniques as Fourier Transform infrared (FTIR), fluorescence (Fluo), Near and Far UV circular dichroism (CD) but also differential scanning calorimetry (DSC).
Various colorimetric assays using UV spectrophotometry (proteins, mRNA, DNA plasmids, excipients, residual impurities), and
More generic testing activities using Inductively Coupled Plasma (ICP), Atomic Absorption Spectroscopy (AAS), residual moisture content determination by coulometric Karl Fisher (KF) or Thermo Gravimetric Analysis (TGA), aluminum content by titration and other USP EU Pharmacopeia tests
You will participate to the analytical method development according to Quality by Design principles, from early vaccine candidates up to method validation for phase III programs, but also in the characterization of some already commercialized vaccines.
Your responsibilities :
You plan & execute lab activities in collaboration with lab technicians and other scientists in the laboratories of the team located in Rixensart and Wavre sites.
You provide support and technical advice to lab technicians.
You participate in lab organization and maintenance, e.g. ordering reagents & consumables, follow-up of instruments maintenance & repair in collaboration with technicians, scientists & lab supports.
You participate in method development according to Quality by Design (QbD) guidelines, in a phase-appropriate manner, and to provide fit-for-purpose analytical methods in interaction with Analytical Product Leaders & Sub teams (APL & AST), as well as Industrialization Leaders (AIL).
You interpret and report results after an extensive check of the raw data quality and participate in the double-check of results generated by lab technicians and other scientists in the platform.
You are deeply involved in generating appropriate analytical documentation, including qualification & validation protocols / reports.
You present results in internal meetings (within the team, to ASTs, etc.).
You may interact with other R&D departments (Preclinical, Drug Substance, Drug Product, Statisticians), as well as with GIO / QC organizations.
You participate in scientific / technology watch in your domain of competency.
Basic Qualifications :
We are looking for professionals with these required skills to achieve our goals :
Master’s degree in Chemistry, Biochemistry, Biophysics, Biology, Bioengineering, Chemical Engineering, Pharmacy, or other relevant discipline.
Awareness of GMP environment / requirements, as well as of Quality by Design principles.
The platform covers diverse analytical technologies : Fourier Transform infrared (FTIR),Fluorescence (Fluo),Near and Far UV circular dichroism (CD),Differential scanning calorimetry (DSC).
UV spectrophotometryInductively Coupled Plasma (ICP),Atomic Absorption Spectroscopy (AAS)Coulometric Karl Fisher (KF)Thermo Gravimetric Analysis (TGA)TitrationsUSP EU - JP Pharmacopeia tests
Expertise in some of these technologies is a must, as well as awareness for all of them.
Ability to lead a method development project within the area of expertise.
Sound scientific methodology and thinking, autonomy; commitment to solve problems and bring innovative solutions to the team.
Communication skills (oral & writing), ability to engage the team; open-minded, result- and quality-oriented.
Native language of the team is French; English fluency is an asset.
Preferred qualifications :
If you have the following characteristics it would be a plus :
Good knowledge of spectrophotometric principles, software, instrumentation, and potential impact on method development is a plus.
Knowledge of method qualification / validation principles.
Knowledge of SAP tool for processes such as results recording / validation, deviation & CAPA management.