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Let's push the boundaries together and make the most of your talents!

Regulatory Bioanalysis Senior Scientist

Location: 

Braine L'alleud, Walloon Brabant, Belgium

Job Function:  Research & Early Development
Job ID:  63938

Help us transform patients' lives.

At UCB, we put our heart, soul, and skills into making a difference for people living with severe disease. Working together to push the boundaries, we blend the best of our talents to unlock innovation.  Will you join us in our pioneering adventure?

 

Regulatory Bioanalysis Senior Scientist

 

Major accountabilities :

 

The role is focussed at supporting regulatory bioanalysis across UCB’s biologics portfolio.

The appointed candidate will be responsible leading a team responsible for the effective transfer of bioanalytical methods to the GLP Bioanalytical facilities and subsequent method validation and sample analysis across all projects in the Immunology and CNS therapeutic portfolios. Extensive experience in ligand binding assay set-up and routine analysis are required covering a range of assay types (PK, ADA, BM) and techniques (ELISA, MSD, GYROS,…).

Experience in mass spectrometric assays will be considered a major plus. Further to the before mentioned skills the candidate will have extensive experience as principal investigator in conducting both pre-clinical and clinical studies including protocol review, conduct of bioanalytical study phases and reporting.

Experience in set-up and use of advanced automation tools will be considered a major advantage for this function. He/she will have a strong appreciation of the regulatory bionanalysis landscape related both to GLP and GCP knowledge as well as in-depth knowledge of relevant guidance documents (FDA/EMA/ICH,…).

 

Apart from being responsible for studies appointed to him/her the individual will lead a small team of principal investigators providing technical and regulatory leadership and coaching and will work closely with bioanalytical scientific managers and bioanalytical sub-teams as well as study monitors, clinical program managers and QA as to assure methods are validated and studies are conducted in a timely manner to the highest quality standard as well as providing scientific guidance on bioanalytical endpoints. He/she will be the main point of contact for all study phases conducted under his/her responsibility. The appointed candidate will be a major contributor to the maintenance of the GLP quality system as well as being involved in optimizing and reshaping the quality system as a function of new activities/workflows being implemented.

 

Education and experience :

 

Required : Master degree
The ideal candidate would be an experienced Bioanalytical Scientist (3-5 years) with a proven track record in method validation as well as conducting bioanalytical study phases..

Experience working in regulatory environment where there quality is paramount would be critical.

 

Specific skills and competences :

 

The ideal candidate would be an experienced Regulated Bioanalytical Scientist with at least 7 years of experience in the pharma/CRO industry with a proven track record in managing teams, conducting method validations as well as conducting bioanalytical study phases..

Experience working in regulatory (GLP/GCP) environment where quality is paramount would be critical.

 

Bioanalysis

 

Extensive experience in bioanalytical method validation and sample analysis

Preferably good knowledgeable in PK, ADA and biomarker analysis

Experience in use of automated liquid handling platforms

Experience with MSD and ELISA platforms

Gyros and and/or LC-MS/MS experience is a plus

 

Regulatory landscape coverage

 

Extensive knowledge of GLP/GCP guidelines as applicable to bioanalysis

Extensive knowledge of bioanalytical method validation guidelines

Extensive experience as principal investigator in pre-clinical and clinical studies

 

Leadership

 

Proven capabilities leading and coaching teams in a bioanalytical environment.

 

IT knowledge

Experience using Watson LIMS or equivalent LIMS system

Good knowledge of Microsoft Office

Graphpad/JMP experience is plus

Experience in using ELN systems is considered a plus

 

Languages

English thorough knowledge, both spoken and written

French will be considered as a major advantage

 

Others

Very good communication skills

Attention to detail and quality of work

VERY well organized, able to function in a complex fast changing environment

Able to influence/coach others inside and outside the direct environment

Able to work independently in implementing/optimizing novel processes/workflows

Team player

Proactive

 

UCB is a global biopharmaceutical company. We focus on discovering and developing innovative medicines and lateral solutions that can transform the everyday lives of people with severe diseases of the immune system – or the central nervous system.

With more than 7500 people in approximately 40 countries, UCB offers an exciting working environment where initiative can flourish and those with a ‘can-do’ attitude can thrive.  Scientific excellence, innovation, co-creation, lateral thinking, reinventing the way we do things…these are some of the key competencies we are constantly developing, and looking for, at UCB.


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