Biopharmaceutical Scientist
3 days ago
About AGC Biologics
AGC Biologics is a global Contract Development and Manufacturing Organization (CDMO) dedicated to bringing life-changing therapies to patients worldwide.
We work closely with our customers to improve patients' lives by developing innovative biopharmaceutical manufacturing processes and producing high-quality biopharmaceutical proteins for clinical testing and commercialization.
The QC Bioassay team at AGC Biologics plays a critical role in ensuring the quality and reliability of our products.
Job Description
We are seeking an experienced Senior Scientist to join our QC Bioassay team. As a key member of our team, 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.
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
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.
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
What We Offer
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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