QC Specialist

ASIT biotech is a Belgian clinical stage biopharmaceutical company focused on the development and future commercialization of a range of breakthrough immunotherapy products for the treatment of allergies. Thanks to its innovative ASIT+TM technology platform, ASIT biotech is currently the only developer of AIT product candidates consisting of a unique mixture of highly purified natural allergen fragments in an optimal size selection. This innovation results in a short treatment, expected to improve patient compliance and real-life effectiveness. ASIT biotech’s product pipeline entails two novel ASIT+™ product candidates targeting respiratory allergy with the highest prevalence (i.e. grass pollen: gp-ASIT+TM and house dust mite: hdm-ASIT+TM), that could significantly expand the current immunotherapy market. The Company believes that its innovative ASIT+™ platform is flexible and would be applicable across a range of allergies.

ASIT biotech has a headcount of 25 staff members, located in Liège, Belgium.

Job Purpose:

The Quality Control Specialist is responsible to set up and validate the analytical methods required to evaluate the overall quality of products, as well as to perform the tests. Will also be responsible to perform preventative maintenance tasks, as well as identify needed areas of improvement.

The Quality Control Specialist report directly to the QA Manager.

Key Responsabilities:

• Coordinate, analyse, perform, and monitor testing of the products (intermediates/final products) to characterise them and to ensure products meet quality specifications.
• Plan, and execute, and report experiment/studies (development of a new analytical method, performance of stability study…) in accordance with the overall development objectives.
• Write and review high-quality experiment protocols (and amendments when applicable).
• Perform the experimentations in agreement with the company standards.
• Analyse, interpret, integrate the data, draw conclusions and present data on assigned experiments and study, write study reports, using the assistance of senior scientific staff as appropriate.
• Present and communicate results/findings in internal meetings.
• Produce and maintain, in a timely manner, proper project documentation in accordance with internal and external requirements.
• Troubleshoot and resolve experimental issues.
• Promote innovation and direct operational improvement and/or evaluation of new approaches and processes.
• Ensure that any circumstances that may affect the quality and integrity of the experiments are identified and documented as they occur and that appropriate corrective actions are taken.
• Function as contact, with guidance from senior scientific staff, for the planning and study scheduling, conduct and reporting.
• Provide technical guidance to the research staff.
• Attend scientific meeting, conferences and training courses to enhance job and professional skills.
• Collaborate with internal and cross functional colleagues to assure testing and releases are completed on time.
• Follow SOPs, test methods and approved written protocols in the laboratory.
• Maintain 5s standard in the lab.
• Performs other duties as assigned or required.

Qualifications:

• Master’s in molecular biology, chemistry, biochemistry or equivalent discipline.
• Former experience in protein production, purification and characterization.
• Specific analytical experience related to the development activities, including amongst others chromatographic (HPLC), electrophoresis and ELISA techniques.
• Utilize strong problem-solving skills to recognize problems and develop corrective actions plan.
• Accurate cross-functional written and verbal communication skills.
• Ability to work independently with a minimum of direction.
• Results orientation with a proven ability to get things done.
• Ability to handle multiple tasks/projects, simultaneously.
• Willingness to work in fast paced and dynamic team environment. Agility.
• Positive attitude, plenty of energy, and excellent interpersonal skills.
• Fluent in French & English.

We offer:

• A challenging leading position within a stimulating and dynamic work environment.
• A variety of interesting contacts with international exposure.
• The opportunity to have direct impact on the results of a high-potential biotech company.
• An attractive compensation package in line with the position responsibilities and your experience.

Interested?

You can apply via the online application form.

Agency calls are not appreciated