Senior Scientist, Analytical Development (CGT)

GeneFab; Alameda (CA); On-site; USD 83,000 - 103,000; Full time

Job summary

GeneFab in Alameda, California seeks a Scientist/Senior Scientist in Analytical Development to lead method development, qualification, and GMP readiness for cell and gene therapies. You will develop and validate CGT release and characterization assays (qPCR/dPCR, Flow Cytometry, ELISA, HPLC), write SOPs, and partner with QC, MSAT, and project teams to ensure quality and timely delivery.

The role requires a BS or PhD with 7+ years (BS) or 2+ years (PhD) in analytical development, with strong

Qualifications

• BS or Ph.D. in Biochemistry, Molecular Biology, or related field.
• 7+ years (BS) or 2+ years (Ph.D.) of analytical development experience.
• Experience with CGT release and characterization assays.
• Proficiency in qPCR/dPCR, Flow Cytometry, ELISA, and HPLC.
• Knowledge of cGMP and regulatory guidelines.

Responsibilities

• Execute development, optimization and troubleshooting of analytical methods for CGT products.
• Lead assay transfers and qualification activities with QC.
• Write qualification protocols and reports per regulatory guidelines.
• Collaborate with cross-functional teams to support project success.
• Represent GeneFab in client meetings and internal reviews.

Skills

Flow Cytometry

dPCR/qPCR

ELISA

HPLC

Biochemistry

Molecular Biology

Education

BS or PhD in Biochemistry / Molecular Biology

Job description

GeneFab in Alameda, California seeks a Scientist/Senior Scientist in Analytical Development to lead method development, qualification, and GMP readiness for cell and gene therapies. You will develop and validate CGT release and characterization assays (qPCR/dPCR, Flow Cytometry, ELISA, HPLC), write SOPs, and partner with QC, MSAT, and project teams to ensure quality and timely delivery.

The role requires a BS or PhD with 7+ years (BS) or 2+ years (PhD) in analytical development, with strong