Skills

Go Organization Project Management Analytics

Job Specifications

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 and 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

• 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 are motivated to further expand your expertise into small molecule analytical development

• 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

About the Company

We are a global provider of drug development and discovery services, encompassing drug substance, drug product, bioanalysis, and CMC regulatory services across small molecules, large molecules, and nanomedicines. Our six international locations offer comprehensive CDMO and BioAnalytical CRO services to a wide range of clients worldwide. We recognize the intricate challenges associated with advancing a promising molecule from the laboratory to the patient. Our multidisciplinary team is eager to collaborate with you throughou... Know more