Scientist I

Germer International - Pharmaceutical Recruiting; Harmonville (PA); On-site; USD 70,000 - 95,000; Full time

Job summary

Germer International - Pharmaceutical Recruiting seeks a Scientist I, Quality Control to perform GMP testing supporting viral vector manufacturing, release and stability programs. The role centers on cell-based potency and infectivity assays and routine mammalian cell culture.

You will independently execute potency/infectivity assays, maintain mammalian cultures, prepare samples, and ensure data integrity while following approved SOPs and safety procedures.

Qualifications

• Bachelor’s degree in biology, cell biology, molecular biology, biochemistry, biotechnology, or related discipline.
• PhD with 0–2 years, MS with 2–3 years, or BS with 4–6 years of relevant lab experience; GMP experience preferred.
• Hands-on experience with mammalian cell culture and aseptic technique.
• Experience with potency, cell-based assays, plate-based assays, or flow cytometry.
• Familiarity with GMP, GDP, and data integrity principles is preferred.

Responsibilities

• Independently perform cell-based potency, infectivity, transduction, and other functional assays for viral vector products and enter data in LIMS.
• Maintain mammalian cell cultures, including passaging, cell counting, viability assessment, and cryopreservation.
• Prepare samples, standards, controls, reagents, and media according to approved procedures.
• Execute testing in accordance with approved methods, SOPs, GMP, GDP, and data integrity requirements.
• Review and document assay results against established system suitability and acceptance criteria.
• Operate and maintain laboratory equipment such as biosafety cabinets, incubators, plate readers, microscopes, and automated cell counters.
• Support assay troubleshooting and method qualification/validation activities.
• Participate in deviations, OOS/OOT investigations, CAPAs, and continuous improvement activities.
• Maintain accurate and contemporaneous laboratory documentation.
• Collaborate with Analytical Development, Manufacturing, and Quality Assurance teams.
• Follow applicable safety and biosafety procedures when handling viral vectors and biological materials.

Skills

Cell culture

Aseptic technique

Data integrity

Documentation

Team collaboration

Education

Bachelor’s degree in biology or related field

MS with 2–3 years or BS with 4–6 years of relevant lab experience; GMP preferred

PhD with 0–2 years of experience

GMP environment experience

Tools

LIMS

Biosafety cabinets

Incubators

Plate readers

Flow cytometry

qPCR/ddPCR

Automated cell counters

Job description

The Scientist I, Quality Control performs GMP testing in support of viral vector manufacturing, release, and stability programs. The role focuses primarily on cell-based potency and infectivity assays and routine mammalian cell culture.

Primary Responsibilities:

• Independently perform cell-based potency, infectivity, transduction, and other functional assays for viral vector products and enter data in LIMS.
• Maintain mammalian cell cultures, including passaging, cell counting, viability assessment, and cryopreservation.
• Prepare samples, standards, controls, reagents, and media according to approved procedures.
• Execute testing in accordance with approved methods, SOPs, GMP, GDP, and data integrity requirements.
• Review and document assay results against established system suitability and acceptance criteria.
• Operate and maintain laboratory equipment such as biosafety cabinets, incubators, plate readers, microscopes, and automated cell counters.
• Support assay troubleshooting and method qualification/validation activities.
• Participate in deviations, OOS/OOT investigations, CAPAs, and continuous improvement activities.
• Maintain accurate and contemporaneous laboratory documentation.
• Collaborate with Analytical Development, Manufacturing, and Quality Assurance teams.
• Follow applicable safety and biosafety procedures when handling viral vectors and biological materials.

Education, Experience, & Qualification:

• Bachelor’s degree in biology, Cell Biology, Molecular Biology, Biochemistry, Biotechnology, or a related discipline.
• PhD with 0-2 years of experience or M.S. with 2-3 years of experience or B.S with 4-6 years of experience of relevant laboratory experience; experience in a GMP environment is preferred.
• Hands-on experience with mammalian cell culture and aseptic technique.
• Experience with potency, cell-based assays, plate-based assays, or flow cytometry.
• Familiarity with GMP, GDP, and data integrity principles is preferred.
• Preferred Experience: AAV and/or lentiviral vector testing, cell-based potency assays, qPCR/ddPCR, ELISA, flow cytometry, or other analytical methods commonly used in cell and gene therapy QC laboratories.