QC Scientist I – Cell-Based Assays (GMP Viral Vectors)

Germer International - Pharmaceutical Recruiting; Harmonville (PA); On-site; USD 65,000 - 90,000; Full time

Job summary

Germer International - Pharmaceutical Recruiting is seeking a Scientist I, Quality Control responsible for GMP testing in support of viral vector manufacturing, release, and stability programs. The role emphasizes cell-based potency, infectivity assays, and mammalian cell culture.

Responsibilities include performing assays, maintaining cultures, data entry, and ensuring adherence to GMP/GDP and data integrity.

Qualifications

• Bachelor’s degree in biology or related discipline.
• Advanced degree with relevant GMP lab experience preferred.
• Hands-on mammalian cell culture and aseptic technique required.
• Experience with potency, cell-based or plate-based assays, or flow cytometry.
• Familiarity with GMP, GDP, and data integrity preferred.
• Experience with AAV or lentiviral testing is a plus.

Responsibilities

• Perform cell-based potency, infectivity, and other assays.
• Maintain mammalian cell cultures and cryopreservation.
• Prepare samples, standards, controls, and media.
• Execute testing per SOPs and GMP standards.
• Review results against criteria and document.
• Operate biosafety cabinets, incubators, plate readers, microscopes.
• Support troubleshooting and method qualification/validation.
• Participate in deviations, CAPAs, and continuous improvement.
• Document lab activities accurately.
• Collaborate with Analytical Development, Manufacturing, QA.
• Follow biosafety procedures when handling materials.

Skills

Cell culture

Aseptic technique

Potency assays

Flow cytometry

qPCR/ddPCR

ELISA

Data integrity

GMP/GDP compliance

Viral vector QC

Collaboration

Education

Bachelor's degree in biology

PhD with related experience

MS with related experience

BS with related experience

Job description

Germer International - Pharmaceutical Recruiting is seeking a Scientist I, Quality Control responsible for GMP testing in support of viral vector manufacturing, release, and stability programs. The role emphasizes cell-based potency, infectivity assays, and mammalian cell culture.

Responsibilities include performing assays, maintaining cultures, data entry, and ensuring adherence to GMP/GDP and data integrity.