Analytical Scientist, Biologics Process Development

Direct Biologics; Poway (CA); On-site; USD 110,000 - 170,000; Full time

Benefits offered by this job

Health Care Plan (Medical)

Company 401k match

Paid Time Off

Holidays

Stock Option

Job summary

Direct Biologics in Poway, CA is seeking an Analytical Scientist to develop, validate, transfer, and support analytical methods for biopharmaceutical products. The role emphasizes molecular biology, biochemistry and cell biology, including PCR, ELISA, next-generation sequencing (NGS), and particle characterization, with collaboration across R&D, QC, Manufacturing, and Regulatory teams.

The candidate will lead method development and validation, support regulatory submissions, and help ensure GMP

Qualifications

• Ph.D. with 2–5 years industry experience or MS/BS with 5–8 years in biotech/pharma.
• Experience in analytical development, validation, transfer, and characterization of biologics.
• Knowledge of GMP analytical testing and regulatory requirements.

Responsibilities

• Develop, validate, transfer, and troubleshoot analytical methods for biologics.
• Lead or participate in method validation, bridging, comparability studies, and transfers.
• Support GMP readiness, investigations, CAPAs, and data integrity.

Skills

PCR/qPCR/ddPCR

ELISA

Biophysical characterization

Cell-based assays

NGS

HPLC/UPLC

Data analysis

Education

Ph.D. in a relevant scientific discipline

MS/BS with 5–8 years of biotech/pharma experience

Tools

Analytical software

GMP documentation systems

Job description

Direct Biologics in Poway, CA is seeking an Analytical Scientist to develop, validate, transfer, and support analytical methods for biopharmaceutical products. The role emphasizes molecular biology, biochemistry and cell biology, including PCR, ELISA, next-generation sequencing (NGS), and particle characterization, with collaboration across R&D, QC, Manufacturing, and Regulatory teams.

The candidate will lead method development and validation, support regulatory submissions, and help ensure GMP