Scientist I

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

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.