Bioanalytical Study Manager
il y a 1 semaine
On-siteOperations, Pre-ClinicalFull time
Boulogne-Billancourt, Île-de-France, France
OVERVIEW
Description
About the Job
Join Excelya, where Audacity, Care, and Energy define who we are and how we work. We believe in creating bold solutions and fostering an inclusive environment where collaboration and individual growth go hand in hand.
This role is an exciting opportunity to contribute to a dynamic, ambitious team. You will play a critical part in driving innovation and making an impact in the clinical research space, while enjoying a stimulating professional environment that encourages personal and intellectual growth.
Monitor outsourced regulated bioanalytical studies to ensure scientific integrity and compliance with GLP/GCP/ICH standards.
Review and approve bioanalytical study documents (protocols, validation reports, sample analysis plans, final reports).
Provide scientific oversight on LC-MS/MS methods for small molecule quantification.
Evaluate and validate bioanalytical data for accuracy, precision, and robustness.
Troubleshoot analytical issues and support CROs with technical guidance.
Perform or supervise non-compartmental pharmacokinetic (NCA) analyses and interpret PK data.
Ensure CRO performance and compliance through monitoring and documentation reviews.
Act as primary liaison between internal stakeholders (Clinical, Non-clinical, Regulatory, QA) and external partners (CROs).
Present bioanalytical and PK results in internal meetings and regulatory submissions.
Maintain high-quality documentation aligned with internal SOPs and regulatory requirements.
**Requirements**:
About You
At Excelya, taking audacious steps is encouraged, so we're looking for individuals who are ready to grow with us and share our values.
**Experience**: At least 5 years of experience in regulated bioanalytical studies within the pharmaceutical or CRO industry, with a proven track record in LC-MS/MS methods and non-compartmental pharmacokinetic (NCA) analysis.
**Skills**: Strong expertise in method development, validation, and sample analysis for small molecules., Solid knowledge of GLP, GCP, ICH M10, and regulatory standards related to bioanalysis, Demonstrated ability to monitor and oversee external CROs, ensuring compliance and scientific quality, Experience with Watson LIMS, ligand-binding assays, or oligonucleotide bioanalysis is a plus.
**Education**: Advanced degree (PhD, PharmD, MSc) in Pharmaceutical Sciences, Analytical Chemistry, Biochemistry, or a related discipline.
**Languages**: Fluency in French & English is required; knowledge of additional languages (e.g., Chinese) is an asset.
**Benefits**:
Why Join Us?
At Excelya, we combine passion for science with enthusiasm for teamwork to redefine excellence in healthcare.
Here's what makes us unique—
We are a young, ambitious health company representing 900 Excelyates, driven to become Europe's leading mid-size CRO with the best employee experience. Our one-stop provider service model — offering full-service, functional service provider, and consulting — enables you to evolve through diverse projects. Working alongside preeminent experts, you will help improve scientific, operational, and human knowledge to enhance the patient's journey.
Excelling with care means benefiting from an environment that values your natural talents, pushes boundaries with audacity, and nurtures your potential, allowing you to contribute fully to our shared mission.
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