Scope

To face our constant growth, we are currently actively looking for a Technical Leader Immunoassays (LBA) – Bioanalysis G(c)LP.

You will work on innovative (bio)pharmaceutical products under development (non-clinical and clinical phases).

You will be part of a team involved in projects outsourced by our clients.

Those projects are related to the development, validation and/or application of analytical methods based on a protocol for the characterisation and quality control of biomolecules.
 

Your mission

You will report to the Analytical Team Manager Bioanalysis and Characterisation.

You will manage a team of 5 to 6 people (Scientists, Analysts and Technicians).

In this role, you will be accountable for:

  • Managing all HR aspects such as:

    • Participation to selection interviews

    • Staff evaluation

    • Ensuring monthly coaching meeting with staff members

  • Co-ordinating projects and resources according to defined priorities

    • Planning of staff members activities

    • Technical troubleshooting

    • Writing and/or verifying protocols & reports on projects for clients,

    • Managing documentation follow-up

    • Validating analysis reports

  • Being the point of contact for clients regarding any technical aspect.

Your profile

Master's / Engineer's degree, specialisation Immunoassays (LBA)

Required

  • Relevant experience working with ELISA on bioanalytical methods

  • Practical experience working in a G(c)LP environment

  • Relevant experience in development and/or validation and/or method transfer of Ligand Binding Assays.

  • Good knowledge of guidances/guidelines applicable to bioanalysis (EMA, FDA, BMV, Ligand Binding Assays, Immunogenicity, ...)

  • Very good communication skills both in French and English (writing scientific documents, reports, protocols and mails, phone conferences, contacts with clients)

  • Good team player

  • Very good organization skills and ability to manage priorities

Plus

  • Good knowledge of the Pharmaceutical sector in a G(c)LP environment

  • Good theoretical knowledge and practical experience of MSD, Luminex and/or Cell-based assays

  • Knowledge of biological medicinal products (mAbs, ADCs, proteins, recombinant peptides) and associated regulations (EMA and FDA).

Why join Quality Assistance?

We are a true career partner.

  • We accelerate people’s access to new medicines.

  • We offer an inspiring work-life balance in a human scale environment.

  • We care about mutual respect, assistance and communication.

  • We listen to your needs and your suggestions.

  • We offer a market-competitive remuneration package including numerous fringe benefits. You will also be provided with a company car.

Visit https://www.quality-assistance.com/quality-assistance/life-quality-assistance to learn more.

About Quality Assistance

Quality Assistance is a leading European Contract Research Organisation providing the pharmaceutical industry with all the analytical services required by EMA and FDA regulations for the development and marketing of innovative human medicinal products.

We assist our clients from candidate selection, through non-clinical and clinical studies, to marketing authorisation, using our state-of-the-art, product-dedicated expertise in analytical sciences. 

For each client project, we design customised solutions, define analytical protocols, develop and validate specific new analytical methods and perform characterisation, stability, pharmacokinetic, biomarker and immunogenicity studies as well as batch release testing, in order to evaluate the Quality, Safety and Efficacy of the given drugs.

The company holds a unique position on the market with all its laboratories on one site, 190 highly qualified professionals and over 35 years’ expertise at the forefront of analytical sciences.

The Quality Assistance environment is GMP, GLP and GCLP/GCP compliant.

Visit https://www.quality-assistance.com/quality-assistance/leading-analytical-cro to learn more.