Scientist, Process Sciences — Analytical Development

Job overview

The Scientist, Process Sciences — Analytical Development role is onsite in Poway, CA. Compensation is not specified. Direct Biologics develops regenerative biologic products and emphasizes patient safety, research, and regulated quality systems. The analytical scientist develops, validates, transfers, and supports methods used to characterize, release, and assess the stability of biopharmaceutical products. The role provides analytical expertise across product development and GMP manufacturing, collaborating with research, process sciences, quality, manufacturing, regulatory teams, and external laboratories.

What you'll do

• Develop, optimize, qualify, validate, transfer, and troubleshoot analytical methods
• design and execute method development and comparability studies
• establish assay criteria and controls
• evaluate analytical variability and data
• support stability, release, and GMP testing
• participate in investigations and quality-system activities
• oversee method transfers and external laboratories
• author and review methods, protocols, reports, specifications, and SOPs
• and support regulatory submissions and responses.

What we're looking for

Skills & competencies

scientist

process sciences

analytical development

poway ca

direct biologics

biologics

pcr

elisa

next-generation sequencing

gmp

method validation

full-time

Work arrangement

• Weekend coverage required

Benefits & perks

• Medical, dental, and vision coverage
• 401(k) match up to 4%
• paid time off
• holidays
• and stock options.

Why this role

Cross-functional analytical development role spanning biologics characterization, GMP support, method transfer, and regulatory documentation.

About the employer

Direct Biologics is hiring for this role. Industry: Research and Development in Biotechnology (except Nanobiotechnology). Sector: 54.