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Flow Cytometry QC Scientist – Cell Therapy bei Eurofins

Eurofins · Exton, Vereinigte Staaten Von Amerika · Onsite

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Company Description:

The work we do at Eurofins Professional Scientific Services matters, and so do our employees. At Eurofins PSS, we put a focus on your professional growth. We provide our employees the ability to break into the biopharmaceutical industry and grow from the bottom up. We have the supportive teams and tools available to invest in you while also affording you work-life balance and a competitive benefits package.

Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins works with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate. Eurofins believes it is a global leader in food, environmental, pharmaceutical and cosmetics products testing and in agroscience CRO services. It is also one of the global independent market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, CDMO, advanced material sciences and in the support of clinical studies.

If you’re looking for a rewarding career, a place to call home, apply with us today!

Job Description:

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:
  • Bachelor’s 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.

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