Cell Therapy QC Scientist Lead
2 weeks ago
We are looking for a highly motivated Cell Therapy QC Scientist Lead to join our team at Roslin CT US Holdings, LLC. In this role, you will be responsible for collaborating with Analytical Development and partner representatives on test methods to support testing of cell therapy products.
About the Role:
- Collaborate with Analytical Development and partner representatives on test methods to support testing of cell therapy products.
- Write protocols, test methods, standard operating procedures (SOPs), and reports in support of methods.
- Oversee and/or participate in execution of method lifecycle activities.
- Support new equipment onboarding and qualification and the implementation of methods in QC in compliance with all applicable quality systems and current cGMPs.
- Develop training approach, training documents, and provide training for new employees.
Requirements:
- Bachelor's degree in scientific discipline and 6+ years of industry experience; MS preferred.
- Experience in a cGMP QC laboratory.
- Ability to function in a team-oriented environment.
- Knowledge and demonstrated understanding of method lifecycle guidances (e.g., ICH).
- Experience in cell-based assays, Flow Cytometry, ELISA, and/or qPCR.
- Excellent/Effective written and verbal communications skills.
- Developed troubleshooting and problem-solving skills.
- Ability to work in a fast-paced, collaborative environment, working with minimal direction (once training has been completed) and able to manage workload based on changing priorities.
- Ability to prioritize objectives from multiple projects and adhere to scheduled timelines while maintaining flexibility and attention to detail.
- Estimated Salary: $90,000 - $125,000 per year, depending on qualifications and experience.
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