Analytical Development Scientist, Biologics | GMP, NGS, Stock

CHEManager International; Poway (CA); On-site; USD 120,000 - 170,000; Full time

Benefits offered by this job

Health care

401k match

Paid Time Off

Holidays

Stock options

Job summary

Direct Biologics is a science-based biopharmaceutical company focused on regenerative biologics. The Analytical Scientist will design and validate analytical methods for characterization, release, and stability of biologics, with emphasis on molecular biology, biochemistry, and cell biology.

You will collaborate across R&D, QC, QA, Manufacturing, and external labs to ensure GMP compliance and robust data integrity. The role requires a Ph.D.

Qualifications

• Ph.D. in a relevant scientific discipline or MS/BS with substantial biotech/pharma experience.
• Experience in analytical method development, validation, transfer and characterization.
• Knowledge of GMP/ICH/FDA/USP requirements and data integrity practices.

Responsibilities

• Develop, validate, transfer, and support analytical methods for biologics.
• Execute method development, validation, bridging, comparability, and transfer studies.
• Support GMP manufacturing readiness and investigations (OOS/OOT).
• Review protocols, data, validation reports, and regulatory documentation.
• Collaborate with R&D, QC, QA, and external CROs/CMOs.

Skills

PCR/qPCR/ddPCR

ELISA

biomolecular activity assays

cell-based assays

biophysical characterization

spectrophotometric methods

fluorescence-based methods

statistical analysis

analytical software

Education

Ph.D. in a relevant discipline

2-5 years industry experience

M.S./B.S. with 5-8 years experience

Tools

HPLC/UPLC

NGS

Job description

Direct Biologics is a science-based biopharmaceutical company focused on regenerative biologics. The Analytical Scientist will design and validate analytical methods for characterization, release, and stability of biologics, with emphasis on molecular biology, biochemistry, and cell biology.

You will collaborate across R&D, QC, QA, Manufacturing, and external labs to ensure GMP compliance and robust data integrity. The role requires a Ph.D.