Analytical Scientist / QC lead

21/09/21

Location

Industriepark-Zwijnaarde 7C, Gent, Belgium

Function type

QC lead

Vacancy

About BioLyo

 BioLyo Technologies is a dynamic biotech company based in Ghent, Belgium, dedicated to the development of live micro-organisms to be used as vaccines or biotherapeutics. The company provides services to third parties to help speed up the development of their Live Bacterial Products (LBPs) by offering GMP compatible and scalable process development. Areas of expertise include medium optimization, fermentation & harvest strategies, pre-and post-lyophilization formulation and lyophilization of live biological products. Analytical method development to determine Critical Quality Attributes (CQAs) and Critical Process Parameters (CPPs) plays a key role during process characterization, a service few CDMO’s offer. As a young growing company, BioLyo has implemented a QA system and aims to offer GMP manufacturing services within 3 years both for Drug Substance and Drug Products in vials, capsules or tablets. Moreover, for Biotechs with development capability in house,  BioLyo is offering consultancy based on its staff's long hands-on experience.

BioLyo wishes to strengthen its team with an Analytical Scientist with the prospect of developing into the Quality Control Manager.

 

Job Description:

 

During the development of an LBP from early to later clinical stages, analytical methods need to evolve from early development to fully validated Quality Control (QC) tests. BioLyo is looking for a professional that is eager to set up and lead a well-functioning analytical team. The Analytical Scientist will report directly to the CEO, together with the Project Leader and Head of Process and Product Development. The position has the potential to develop into the  Quality Control manager once BioLyo's GMP facility comes on line. The Analytical Scientist's responsibilities are several and diverse, as is to be expected in a small CD(M)O:

  • Write analytical methods, set up the lab work,  analyze data and write reports

  • Plan and align analytical activities, arrange day to day planning

  • Develop (new) product-related assays (cell based, ELISA, microbiological)

  • Set up new assays related to measuring CQAs using (bio)chemical assays, HPLC, IC

  • Write method validation protocols

  • Coordinate trending and stability studies

  • Teach and train technicians in the lab as well as outside the lab

  • Ensure adequate analytical equipment maintenance & qualification status 

  • Write SOPs and WINs compliant with the current QA system

  • Liaise with the Project Leader to translate customer requests into work plans

  • Organize the necessary hardware, consumables and staffing to carry out the work programs

  • Brainstorm with the CEO and the team to keep track of new developments in the LBP field

 

Education and Competences:

  • Master of Science or PhD degree in pharmaceutical sciences, chemistry, biochemistry or related discipline

  • At least 3 years of experience in the biotech sector, preferably relevant CDMO experience

  • Experienced in working under GMP conditions, preferably with LBPs

  • Knowledge of EP/USP based analytical method qualification and validation

  • Working knowledge of fermentation, tangential flow filtration, lyophilization

  • Know-how of statistical data analysis software is a plus

  • Good planning & organization skills

  • Good oral communication, reporting and presentation skills

  • Fluent in English and Dutch, written and spoken.

  • Ability to work with a motivated team in a dynamic and fast-paced environment

  • Willingness, within reason, to work outside working hours if necessary

  • Curious and critical, pragmatic and problem solving, accurate, inventive and precise

 

If you are interested in this job offer, please send your application, including your CV and a motivation letter before October 21st to Liesbeth Vercruyssen

Job application