Senior Analytical Expert
3 days ago
About Our Purpose
At AGC Biologics, our purpose is to bring hope to life by enabling life-changing therapies for patients around the globe.
We create a healthier and happier tomorrow by working side-by-side with our customers to improve patients' lives through the development and production of new biopharmaceuticals.
About Our Mission
Our mission is to be a trusted partner in the biopharmaceutical industry, providing high-quality products and services that meet the evolving needs of our customers.
We achieve this by fostering a culture of innovation, collaboration, and excellence in everything we do.
About the Role
We are currently seeking an experienced Senior Scientist to join our QC Bioassay team.
In this role, you will be responsible for reviewing and approving analytical results, method validations, and compliance activities.
You will also participate in troubleshooting and scientific support on a broad range of bioassay methods, drive compliance documents related to QC activities, and collaborate with multiple stakeholders within QC and cross-functional departments.
Key Responsibilities
- Review and approval of analytical results
- Responsible for method validations according to current ICH guidelines
- Participate in troubleshooting and scientific support on a broad range of bioassay methods
- Drive compliance documents related to QC activities
- Collaboration with multiple stakeholders both within QC and cross-functional departments including Analytical Development, Project Managers, and QA
- Ensuring all tasks performed in cGMP compliance
About Our Team
You will join a team of experienced professionals who share your passion for delivering high-quality products and services.
Our team is collaborative, supportive, and committed to excellence in everything we do.
About Our Requirements
To be successful in this role, you should have a M.Sc. or Ph.D. degree in Life Sciences and experience from the pharmaceutical industry, preferably from Quality Control or an Analytical Development department.
You should be able to thrive working in a dynamic environment and keep track of multiple simultaneous tasks when priorities are frequently changing.
About Our Preferred Skills and Qualifications
- Experience with bioassay methods
- A strong analytical mindset and troubleshooting skills
- Structured and detail-oriented but also demonstrate a pragmatic can-do attitude
- Hands-on experience with handling laboratory investigations, deviations, and CAPAs
- Experience with working in a cGMP setting according to EU and US guidelines
- Good communication skills and a service-minded attitude to meet customer requests in a positive and professional way
- Fluency in English is a requirement as English is our corporate language
About Our Benefits
As a valued member of our team, you will have the opportunity to contribute to the development of new biopharmaceuticals and make a meaningful impact on patients' lives.
We offer a dynamic and supportive work environment, opportunities for growth and professional development, and a competitive compensation package.
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