Analytical Scientist, Biologics – GMP & ELISA (Stock Options)

CHEManager International; Poway (CA); On-site; USD 90,000 - 140,000; Full time

Benefits offered by this job

Health Care Plan (Medical, Dental &amp

Company 401k match up to 4%

Paid Time Off (Vacation & Sick)

Holidays

Stock Option

Job summary

Direct Biologics seeks an Analytical Scientist to develop, validate, transfer, and support analytical methods for biologics, focusing on molecular biology, biochemistry, and cell biology. The role collaborates across R&D, QA, QC, Manufacturing, Regulatory/CMC, and CROs/CDMOs to ensure robust assays from development through GMP testing.

The position requires Ph.D. with 2–5 years of industry experience or MS/BS with 5–8 years in biotech/pharma, and expertise in PCR/ELISA/NGS and related analytical

Qualifications

• Ph.D. in a relevant scientific discipline with 2-5 years of 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, ICH/FDA/USP requirements.
• Experience with external labs, CROs, or CMOs/CDMOs is preferred.

Responsibilities

• Develop, validate, transfer, and support analytical methods for biologics across lifecycle stages.
• Lead method development, validation, bridging, comparability, and transfer studies.
• Establish method parameters, acceptance criteria, and controls; evaluate performance and variability.
• Perform forced degradation studies to support stability-indicating methods.
• Support GMP manufacturing readiness and investigations (OOS/OOT, CAPAs, deviations).
• Provide analytical content for regulatory submissions and health authority responses.

Skills

PCR/qPCR/ddPCR

ELISA

Biomolecular activity assays

Biophysical characterization

Cell-based assays

Spectrophotometric methods

NGS

Quality testing (pH, osmolality, endot

Education

Ph.D. in a relevant scientific discipline

M.S./B.S. with related biotech/pharma experience

Tools

HPLC/UPLC

Job description

Direct Biologics seeks an Analytical Scientist to develop, validate, transfer, and support analytical methods for biologics, focusing on molecular biology, biochemistry, and cell biology. The role collaborates across R&D, QA, QC, Manufacturing, Regulatory/CMC, and CROs/CDMOs to ensure robust assays from development through GMP testing.

The position requires Ph.D. with 2–5 years of industry experience or MS/BS with 5–8 years in biotech/pharma, and expertise in PCR/ELISA/NGS and related analytical