Scientist Ii, Immunoassay Method Validation
il y a 1 semaine
Performing critical work that impacts our industry and human health while problem solving and innovating in the field - that’s what Scientists at Active Biomarkers get to do every day. If that gets you excited too, then maybe working as a Scientist II for Bioanalytical Methods at Active Biomarkers is a role to consider. The Scientist II is at the very heart of Active Biomarkers operations. She/he designs, coordinates and reports several method validation and sample testing projects, in close interaction with our team of analysts and our clients. The Scientist II contributes intellectually to the progress of the project while acting as a mentor to peers in a supportive manner when necessary and as a day-to-day point of contact with our clients.
When you work as Scientist at Active Biomarkers, you get to further our mission, carrying out and supervising all aspects of our studies.
**In this role, we’ll rely on you to**:
- Design, coordinate and complete complex immune-assay method validation and testing for preclinical and clinical studies.
- Act as the main point of contact for clients from study kick-off to study completion, including oral and written reporting
- Lead multiple projects in validation/testing of bioanalytical methods complying to applicable ICH/FDA/EMA guidelines under GLP/GCLP environment
- Revise, question, explain and follow SOPs
- Be accountable for the design, execution and delivery of multiple projects (safety, quality, right first time, on time, budget), including completion of project dashboards
- Coordinate a technical team for the good execution of experiments for client sponsored projects.
- Create study plans, project data summaries and presentations/ reports according to the company’s standards
- Perform all method validation operations, including documentation and reporting of all analytical performances
- Being proficient on several technologies and equipment to include at least ELISA and MSD, and any other equipment as required.
- Troubleshoot basic testing and/or analytical method related issues
- Escalate technical and customer issues in a timely fashion
- Critically review and interpret raw data & information
- Develop good client interactions and relationships, carry out timely reporting
- Act as an advocate for Active Biomarkers at external meetings, external and internal functions when required
- Provide technical and scientific input to the Sales team into Customer proposals / discussions
- Possess excellent time management, multi-tasking and strong organizational skills.
You’ll do all of this in our state-of-the-art labs constructed explicitly for our purposes. You’ll be counted on to share your expertise as a mentor to those earlier in their career, have direct access to Active Biomarkers leaders to share your vision and ideas, be trusted as an expert in your field, and experience opportunities to further advance your own career and knowledge. You’ll also experience the benefit of a casual work environment. And every day, you’ll be part of decisions and work that pioneers the latest drug development in human and animal healthcare.
At Active Biomarkers, demand for our expertise in bioanalytical and biomarker services is growing, and now is a great time to join us and be part of our team of dedicated experts who are together, improving the world’s health (Note, this is a representative summary of responsibilities and is not meant to be exhaustive.)
**WHO YOU ARE**:
You will thrive at Active Biomarkers if you enjoy a relational environment, are purpose
- and values-driven, embrace constant development and supportive leadership, and enjoy being part of innovative work.
**To qualify specifically for this role, you will have**:
- Masters or PhD in life sciences
- 3+ years of combined work experience in the field of analytical method development or validation, including biochemistry and/or ligand binding assays and/or cell-based assays.
- Subject Matter Expert in at least one bioanalytical technique and a wider knowledge of other methods
- Hands-on experience with the regulatory and scientific conduct of method development, validation and troubleshooting in support of PK, immunogenicity (ADA) and PD studies (soluble and cellular biomarkers) involving innovative therapeutics
- GLP & GCLP awareness desirable
- Strong communication skills, with the ability to transfer knowledge and communicate effectively to internal/external stakeholders
- Excellent social skills, ability to work in matrixed teams and collaborate with diverse partners cross-functionally
- Demonstrated ability to think critically with excellent problem solving and troubleshooting skills
- Demonstrate high ethical standards, good judgement, and trustworthiness
- A passion for learning
- Fluency in English and French
**WHO WE ARE**:
We are a fast-growing contract research organization (CRO) based in Lyon, pioneering the latest drug development in both human and animal health fields. Dema
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