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Scope

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

For each customer and each 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.

To face our constant growth, we are currently actively looking for a Technical Leader.

You will be requested to work on projects for the characterisation and quality control of Biomolecules.

Your mission

You will report to the Analytical Team Manager Biologics and Bioassays.

You will manage a team of 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 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

Scientific background with good knowledge of biologics (antibodies, ADCs, mAbs, proteins, etc.)

Required

  • Relevant working experience in a regulated environment in the pharmaceutical industry within a GxP environment

  • Good knowledge and working experience with cell lines amplification

  • Good knowledge of Cell-based assays and/or Ligand binding assays

  • Working experience with one of the following tests:

    • Cytotoxicity testing (Antibody-Dependent Cell-Mediated Cytotoxicity (ADCC), and Complement Dependent Cytotoxicity (CDC), …)

    • Reporter gene assays

    • Cell death,

    • Proliferation

    • ELISA

  • Experience in development, validation and/or application of analytical methods

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

  • Good knowledge of pharmaceutical guidances

Pluses

  • First experience in team management

  • Knowledge of the following techniques:

    • FACS

    • MSD (electrochemiluminescence)

    • Luminex

    • SPR (Biacore)

    • qPCR

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.

JOB 188
People & Project Management