Leading Scientist for Quality Control and Assurance
1 week ago
About FUJIFILM Diosynth Biotechnologies
">FUJIFILM Diosynth Biotechnologies is a world leading Contract Development Manufacturing Organization (CDMO) serving customers in the pharmaceutical industry.
We are looking for a skilled scientist to join our fast-growing company as a Quality Control Chemist. This role is an excellent opportunity to advance your career in a cGMP QC laboratory, working closely with experienced professionals who share our passion for quality and excellence.
About the Role
- You will be scientifically responsible for assays performed in QC Chemistry regarding testing, improvements, troubleshooting, and investigations in compliance with cGMP.
- Laboratory support will be provided if unexpected analytical method trends are observed.
- Daily QC manager approval of test results for commercial products will be required.
- Handling deviations, invalid assays, laboratory exceptions, CAPAs, and Change Controls will be part of your responsibilities.
- You will collaborate closely with our Analytical Development department when transferring new methods for testing in QC laboratories.
- Implementation of new instruments in close collaboration with the QC Instrument supporting team will be another key responsibility.
- Authoring technical protocols and reports as well as change control requests for ensuring successful execution of qualification and analytical improvement projects will be expected.
- You must ensure compliance with cGMP and participate in audits and inspections.
Requirements and Qualifications
To be successful in this role, you should have a Master's Degree in Biochemistry, Biology, Biotechnology, Pharmaceutical Sciences, or similar. A PhD and/or experience from the pharmaceutical industry would be beneficial.
Knowledge of GMP and quality systems is essential. Experience with various chemistry methods, both compendial and HPLC/CE-SDS/cIEF testing, is desirable. Method validation, qualification, and troubleshooting related to DS and DP are advantages.
A can-do attitude, energy, and understanding of cGMP QC laboratory requirements are essential. Excellent collaboration skills and the ability to handle a busy environment with many changing priorities without losing your good mood and overview are necessary.
Fluency in English is required as it is our corporate language.
The salary for this role is approximately $65,000-$80,000 per year, depending on qualifications and experience.
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