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Project Leader
3 weeks ago
Location: Ballina, IE, F26D786
For 75 years, Charles River employees have collaborated to contribute to the discovery, development, and safe production of new drug therapies. When you become part of our team, you'll have a significant impact on global health. Whether your expertise lies in life sciences, finance, IT, sales, or another field, your skills will be crucial to our work. In return, we'll assist you in crafting a fulfilling career you're passionate about.
Job SummaryWe are in search of a Scientific Project Leader for our Biologics Division in Ballina, Co. Mayo, Ireland. This role involves closely collaborating with new and existing clients to develop customized project plans. Utilize your strong technical background in in vitro cell-based assay methodologies (adhering to GMP standards) to meet client requirements and serve as a key contact throughout the project lifecycle.
This position will report to the Cell Based Assay Development Manager. Key duties and responsibilities include:
- Research and develop new in-vitro cell-based methodologies to fulfill client needs and company objectives.
- Ensure validation of new methods according to ICH guidelines, when applicable.
- Create and execute study plans in strict compliance with regulatory standards.
- Coordinate with the Quality Department for audit responses, deviation reports, and study report compilation.
- Lead laboratory investigations when necessary.
- Report project progress to Management.
- Provide technical training to the scientific team as necessary.
- Engage with clients on current and upcoming projects.
- Address technical inquiries during audits.
- Coordinate qualification and validation of new equipment adhering to standards.
- Ensure approval of vendors, chemicals, and consumables per company procedures.
- Develop and update standard operating procedures.
- Conduct risk assessments for various projects as needed.
- Schedule project-related tests to ensure timely execution and reporting.
The following minimum requirements apply to the Project Leader role:
- MSc. or PhD in a relevant science discipline (e.g. Cell Biology / Biomedical Science)
- Demonstrated experience in a GMP regulated setting (EMEA/FDA) within the Pharmaceutical/Medical Device/CRO Industry.
- Expertise in study design, assay development, optimization, ICH analytical validation, and project management.
- Essential experience in In-Vitro bioassays (e.g. potency/proliferation/differentiation assays, colorimetric fluorescence assays etc.).
- Capability to manage multiple studies simultaneously.
- Familiarity with statistical software.
- Problem-solving skills and ability to work autonomously.
About Biologics Testing Solutions
With over 50 years of experience and regulatory proficiency, the Charles River Biologics group caters to complex projects for biotech and pharma firms globally. Offering services like contamination and impurity testing, protein characterization, bioassays, viral clearance studies, and stability and lot release programs, we aid clients throughout the biologic development cycle, from cell bank establishment to market release. Whether clients require standalone services or a tailored testing package, our Biologics team can provide a solution that fits their needs. Annually, we deliver more than 20,000 biologic testing reports and support over 200 licensed products with our solutions.
About Charles River
Charles River, an early-stage CRO, leverages its foundation in laboratory animal science to offer a range of discovery and safety assessment services, both GLP and non-GLP. We also deliver products and services to support clinical lab testing and manufacturing operations of clients. This diverse portfolio enables clients to adopt a more flexible drug development model, reducing costs, enhancing productivity, and accelerating time to market. With a global workforce of over 20,000 across 110 facilities in 20+ countries, we are strategically positioned to address clients' challenges comprehensively. Our diverse clientele includes global pharma firms, biotechs, government entities, hospitals, and educational institutions worldwide.
At Charles River, we are dedicated to enhancing lives globally. Our commitment to excellent science and a clear purpose drives us daily, knowing that our efforts contribute to better health worldwide. We take pride in having supported the development of 86% of FDA-approved drugs in 2021. We value diversity and inclusion, actively working towards these principles daily by recognizing and recruiting talent from all backgrounds.
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