Senior Scientist, Cell Therapy Analytics & Methods

Orca Bio; Sacramento (CA); On-site; USD 120,000 - 170,000; Full time

Benefits offered by this job

Pre-IPO equity

Annual bonus

Medical, dental, vision benefits

Subsidized on-site meals

Job summary

Orca Bio is leading the next generation of cell therapies from its Sacramento facility. We are seeking an experienced analytical development leader to own potency, mechanism of action studies, product characterization, and release testing methods for early- and late-stage programs.

You will author CMC analytical content for BLA submissions, validate methods, and transfer assays across labs while collaborating with Process Development, Manufacturing, QC, and QA teams to drive commercialization

Qualifications

• PhD is required with 5–8+ years of industry experience.
• MS candidates may be considered with an outstanding track record in analytical development.
• Working knowledge of QC and cGMP requirements for biopharmaceuticals.

Responsibilities

• Develop and optimize multiparametric flow cytometry and cell-based functional assays for cell therapy products.
• Lead validation of analytical methods for release and stability testing, including writing and reviewing protocols and reports.
• Drive method transfers between labs, including transfer plans, protocols, execution, and reports.
• Author CMC analytical content for BLA submissions and commercial launch preparation.
• Collaborate with Process Development, Manufacturing, QC, QA and other teams; present data to stakeholders.

Skills

Flow cytometry

Cell-based assays

Cross-functional collaboration

Data analysis

Scientific writing

Project management

Communication skills

Education

PhD in Pharmaceutical Sciences or related field

MS with outstanding analytical development track record

Job description

Orca Bio is leading the next generation of cell therapies from its Sacramento facility. We are seeking an experienced analytical development leader to own potency, mechanism of action studies, product characterization, and release testing methods for early- and late-stage programs.

You will author CMC analytical content for BLA submissions, validate methods, and transfer assays across labs while collaborating with Process Development, Manufacturing, QC, and QA teams to drive commercialization