Lead Flow Cytometry Analytics for Cell Therapy

Roche; South San Francisco (CA); On-site; USD 147,000 - 272,000; Full time

Benefits offered by this job

Relocation assistance

Discretionary annual bonus

Job summary

Genentech in South San Francisco, CA, is seeking a highly motivated leader to guide the flow cytometry analytical development team in cell therapy programs. You will establish robust, state-of-the-art assays and collaborate across Process Development, QC, Manufacturing, Regulatory Affairs, and other functions to ensure product quality and process performance.

You will mentor three scientists, apply QbD and cGMP principles, and drive method transfer to GMP QC and external partners.

Qualifications

• PhD in Biological Sciences or related field; 3+ years in biotech/pharma (cell therapy) if PhD, or MS/BS with 9+ years.
• Proven supervision and mentoring of analytical development teams.
• Strong knowledge of cGMPs, ICH, FDA framework and QbD principles.
• Experience with DOE and statistical methods for method lifecycle management.
• Excellent written and verbal communication; able to author CMC documents.

Responsibilities

• Lead studies for development of robust multicolor flow cytometry methods and cell-based assays.
• Represent analytical development in CMC and program meetings.
• Manage method transfer to GMP QC and external partners.
• Foster collaboration with cross-functional groups to support method development and product characterization.
• Provide training and mentorship to other teams on flow cytometry methods.
• Stay current with industry trends and evaluate platforms and literature.
• Draft technical reports, SOPs, and test protocols.
• Lead a team of analytical development scientists toward program milestones.

Skills

Supervision

Mentoring

DOE

Statistical methods

Regulatory communication

Cross-functional collaboration

Adaptability

Education

PhD in Biological Sciences

MS/BS with 9+ years experience

Tools

Multicolor flow cytometry

Cell-based assays

qPCR

ddPCR

ELISA

NGS

Job description

Genentech in South San Francisco, CA, is seeking a highly motivated leader to guide the flow cytometry analytical development team in cell therapy programs. You will establish robust, state-of-the-art assays and collaborate across Process Development, QC, Manufacturing, Regulatory Affairs, and other functions to ensure product quality and process performance.

You will mentor three scientists, apply QbD and cGMP principles, and drive method transfer to GMP QC and external partners.