Senior / Principal Scientist, CMC Analytical Development

Job overview

The Senior / Principal Scientist, CMC Analytical Development role is onsite in Sacramento, CA, with an annual salary range of $120,000–$170,000. Orca Bio’s analytical development work supports cell therapy programs and preparation for commercialization, advancing its goal of improving outcomes for people with blood cancer. The scientist develops, validates, and transfers analytical methods for cell therapy products, including potency, mechanism-of-action, characterization, and release testing. The role also contributes CMC analytical content for regulatory submissions and works across Process Development, Manufacturing, QC, and Quality to support program readiness.

What you'll do

• Develop and optimize multiparametric flow cytometry and cell-based functional assays
• lead validation of release and stability methods
• plan and execute method transfers
• conduct product characterization, potency, mechanism-of-action, comparability, and stability studies
• analyze and present data
• author and review protocols, reports, SOPs, and BLA analytical sections
• collaborate with Process Development, Manufacturing, QC, and Quality.

What we're looking for

Skills & competencies

senior scientist

principal scientist

cmc analytical development

cell therapy

flow cytometry

cell-based assays

method validation

method transfer

bla submissions

sacramento ca

orca bio

$120k–$170k/year

Work arrangement

• Weekend coverage required

Benefits & perks

• Pre-IPO equity, annual bonus, medical, dental and vision benefits, PTO, 401(k), life and disability coverage, parental leave, and subsidized on-site lunches and snacks.

Why this role

Hands-on cell therapy analytical development role with flow cytometry and cell-based assay focus; PhD required, though MS candidates with an outstanding track record may be considered.

About the employer

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