We are seeking a highly motivated Flow Cytometry QC Scientist to support Quality Control operations in a GMP-compliant cell therapy environment. This role is responsible for executing analytical testing to ensure the safety identity strength purity and quality of cell-based products. The primary focus will be on flow cytometry assays with cross-training in complementary analytical methods such as ELISA qPCR and cell culture.
Key Responsibilities:
- Perform flow cytometry testing to support assays including percent transduction efficiency and CD90 expression.
- Execute analytical test methods for in-process samples bulk drug substance final drug product and raw materials for release and stability.
- Coordinate and schedule testing activities in alignment with manufacturing timelines.
- Review and maintain compliance of SOPs and analytical test procedures.
- Ensure accuracy and completeness of QC raw data in accordance with SOPs and regulatory standards.
- Troubleshoot assay performance and investigate nonconforming data.
- Respond to Out of Specification (OOS) results initiate investigations and execute CAPAs.
- Uphold data integrity and document work using Good Documentation Practices and ALCOA principles.
- Maintain laboratory cleanliness organization and logbook accuracy.
- Conduct internal audits and GEMBA walk-throughs to ensure compliance.
- Author and execute protocols technical reports and change controls.
- Perform equipment standardizations and qualifications as needed.
- Train and mentor other laboratory personnel.
- Collaborate with Manufacturing Quality Assurance and Facilities to meet operational goals.
Qualifications :
- Bachelors degree in Biochemistry Chemistry or a related scientific discipline.
- Minimum 2 years of experience in a GMP Quality Control environment with hands-on flow cytometry.
- At least 2 years of mammalian cell culture experience in academic or industry settings.
- Minimum 1 year working in a cGMP and GDP-regulated pharmaceutical environment.
- Familiarity with analytical instruments such as flow cytometers UV plate readers microscopes and pH meters.
- Strong verbal and written communication skills.
- Willingness to work occasional off-shift and weekends.
- Must be eligible to work in the U.S. indefinitely without sponsorship.
Additional Information :
Position is Full Time First Shift - some evening and weekend work may be required as needed. Candidates currently living within a commutable distance of Exton PA are encouraged to apply.
Excellent full-time benefits include:
- Medical Coverage: Comprehensive medical insurance options
- Dental & Vision: Full dental and vision coverage available
- Life & Disability Insurance: Employer-sponsored plans
- Retirement: 401(k) plan with company match
- Paid Time Off: Vacation days paid holidays and additional PTO options
Eurofins USA PSS Insourcing Solutions is a Disabled and Veteran Equal Employment Opportunity employer.
Remote Work :
No
Employment Type :
Full-time
We are seeking a highly motivated Flow Cytometry QC Scientist to support Quality Control operations in a GMP-compliant cell therapy environment. This role is responsible for executing analytical testing to ensure the safety identity strength purity and quality of cell-based products. The primary foc...
We are seeking a highly motivated Flow Cytometry QC Scientist to support Quality Control operations in a GMP-compliant cell therapy environment. This role is responsible for executing analytical testing to ensure the safety identity strength purity and quality of cell-based products. The primary focus will be on flow cytometry assays with cross-training in complementary analytical methods such as ELISA qPCR and cell culture.
Key Responsibilities:
- Perform flow cytometry testing to support assays including percent transduction efficiency and CD90 expression.
- Execute analytical test methods for in-process samples bulk drug substance final drug product and raw materials for release and stability.
- Coordinate and schedule testing activities in alignment with manufacturing timelines.
- Review and maintain compliance of SOPs and analytical test procedures.
- Ensure accuracy and completeness of QC raw data in accordance with SOPs and regulatory standards.
- Troubleshoot assay performance and investigate nonconforming data.
- Respond to Out of Specification (OOS) results initiate investigations and execute CAPAs.
- Uphold data integrity and document work using Good Documentation Practices and ALCOA principles.
- Maintain laboratory cleanliness organization and logbook accuracy.
- Conduct internal audits and GEMBA walk-throughs to ensure compliance.
- Author and execute protocols technical reports and change controls.
- Perform equipment standardizations and qualifications as needed.
- Train and mentor other laboratory personnel.
- Collaborate with Manufacturing Quality Assurance and Facilities to meet operational goals.
Qualifications :
- Bachelors degree in Biochemistry Chemistry or a related scientific discipline.
- Minimum 2 years of experience in a GMP Quality Control environment with hands-on flow cytometry.
- At least 2 years of mammalian cell culture experience in academic or industry settings.
- Minimum 1 year working in a cGMP and GDP-regulated pharmaceutical environment.
- Familiarity with analytical instruments such as flow cytometers UV plate readers microscopes and pH meters.
- Strong verbal and written communication skills.
- Willingness to work occasional off-shift and weekends.
- Must be eligible to work in the U.S. indefinitely without sponsorship.
Additional Information :
Position is Full Time First Shift - some evening and weekend work may be required as needed. Candidates currently living within a commutable distance of Exton PA are encouraged to apply.
Excellent full-time benefits include:
- Medical Coverage: Comprehensive medical insurance options
- Dental & Vision: Full dental and vision coverage available
- Life & Disability Insurance: Employer-sponsored plans
- Retirement: 401(k) plan with company match
- Paid Time Off: Vacation days paid holidays and additional PTO options
Eurofins USA PSS Insourcing Solutions is a Disabled and Veteran Equal Employment Opportunity employer.
Remote Work :
No
Employment Type :
Full-time
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