Ardena
About us
Ardena
is a leading contract development organization for the pharmaceutical industry. We assist pharmaceutical companies, from virtual biotech to big pharma, in bringing their valued molecule(s) to the clinic and market. We provide a comprehensive and integrated portfolio of drug substance and drug product development, manufacturing, logistics and bioanalytical services.
The
Ardena Group
is operating from five sites in Europe and one in US. For the Ardena branch based in Mariakerke (Gent, Belgium), we are looking for an
ANALYTICAL SCIENTIST WHAT YOU WILL WORK ON Ardena Gent
guides a worldwide portfolio of customers through the processes of formulation and analytical development, the preparation of regulatory dossiers and the manufacturing and labeling of early-phase clinical materials according to GMP appropriate standards.
The analytical laboratory plays a key role in the development and validation of analytical methods to characterize drugs and to perform quality control testing on incoming raw materials and on the finished clinical materials.
YOUR KEY RESPONSIBILITIES
You prepare and perform development and quality control analyses according to method descriptions and protocols
You act as the go-to expert for oligonucleotide or biological product analytics within the organization
You troubleshoot complex analytical challenges and propose innovative solutions.
You develop, install and validate analytical methods
You document and report the analyses and the obtained results in line with GMP standards
You plan, organize and control independently the attributed analytical package
You actively contribute to procedural documents and improvement projects related to the general lab management
You mentor and train associate scientists in analytical techniques
You communicate and interact with method developer(s), compliance and project management and you align timings with Lab management and Project management timelines
You assist the Analytical Group Leader and the Project Manager in technical discussions with the Contract Giver
You initiate and document investigations and non-conformances
YOUR PROFILE
You have a PhD degree in science (preferably a PhD)
You have profound experience in development of chromatographic analytical methods such as HPLC, UPLC and biological assays. You have over 3 years of relevant professional laboratory experience e.g. chromatography (HPLC, UPLC, GC), dissolution, Karl Fisher and spectro (UV-VIS, IR). You have strong knowledge of oligonucleotide chemistry and biological drug product attributes.
You have experience in a regulated quality control environment (GMP)
You are flexible, a problem solver and a team player
You have an analytical mindset and you are stress resistant
You are fluent in English (written as well as spoken)
WHAT WE OFFER
An attractive and tailor‑made remuneration package including extra‑legal benefits such as
Compensation if you come to work by bike
Meal vouchers
Group/hospitalization insurance
Flexible working hours
32 days holiday a year
Ability to grow your skills in a rapidly growing company with international customer portfolio
A dynamic working environment
#J-18808-Ljbffr
is a leading contract development organization for the pharmaceutical industry. We assist pharmaceutical companies, from virtual biotech to big pharma, in bringing their valued molecule(s) to the clinic and market. We provide a comprehensive and integrated portfolio of drug substance and drug product development, manufacturing, logistics and bioanalytical services.
The
Ardena Group
is operating from five sites in Europe and one in US. For the Ardena branch based in Mariakerke (Gent, Belgium), we are looking for an
ANALYTICAL SCIENTIST WHAT YOU WILL WORK ON Ardena Gent
guides a worldwide portfolio of customers through the processes of formulation and analytical development, the preparation of regulatory dossiers and the manufacturing and labeling of early-phase clinical materials according to GMP appropriate standards.
The analytical laboratory plays a key role in the development and validation of analytical methods to characterize drugs and to perform quality control testing on incoming raw materials and on the finished clinical materials.
YOUR KEY RESPONSIBILITIES
You prepare and perform development and quality control analyses according to method descriptions and protocols
You act as the go-to expert for oligonucleotide or biological product analytics within the organization
You troubleshoot complex analytical challenges and propose innovative solutions.
You develop, install and validate analytical methods
You document and report the analyses and the obtained results in line with GMP standards
You plan, organize and control independently the attributed analytical package
You actively contribute to procedural documents and improvement projects related to the general lab management
You mentor and train associate scientists in analytical techniques
You communicate and interact with method developer(s), compliance and project management and you align timings with Lab management and Project management timelines
You assist the Analytical Group Leader and the Project Manager in technical discussions with the Contract Giver
You initiate and document investigations and non-conformances
YOUR PROFILE
You have a PhD degree in science (preferably a PhD)
You have profound experience in development of chromatographic analytical methods such as HPLC, UPLC and biological assays. You have over 3 years of relevant professional laboratory experience e.g. chromatography (HPLC, UPLC, GC), dissolution, Karl Fisher and spectro (UV-VIS, IR). You have strong knowledge of oligonucleotide chemistry and biological drug product attributes.
You have experience in a regulated quality control environment (GMP)
You are flexible, a problem solver and a team player
You have an analytical mindset and you are stress resistant
You are fluent in English (written as well as spoken)
WHAT WE OFFER
An attractive and tailor‑made remuneration package including extra‑legal benefits such as
Compensation if you come to work by bike
Meal vouchers
Group/hospitalization insurance
Flexible working hours
32 days holiday a year
Ability to grow your skills in a rapidly growing company with international customer portfolio
A dynamic working environment
#J-18808-Ljbffr