Senior Scientist, Reagent & Flow Cytometry Assays

Planet Pharma; Milpitas (CA); On-site; USD 69,000 - 73,000; Full time

Job summary

Planet Pharma seeks a Scientist III to support sustainment and continuous improvement of reagent and assay products throughout their lifecycle. You will work with cross-functional teams to ensure documentation is robust and compliant while enabling development pipelines.

You bring a strong background in immunology and flow cytometry, with proven ability to lead projects, author technical files, and participate in audits to keep products inspection-ready.

Qualifications

• Bachelor’s degree in Life Science required.
• At least 5 years of related experience in a research, clinical/diagnostic, or biotech R&D environment.
• Strong understanding of immunology, flow cytometry, assay development or related cell-based research technologies.
• Experience authoring and reviewing technical documentation.
• Demonstrated ability to lead projects independently and collaborate across functions.
• Excellent written and verbal communication skills.

Responsibilities

• Support reagent and assay sustainment projects for marketed products.
• Review and approve technical documentation to support reagent and assay products.
• Review design history files, validation reports, risk assessments, technical files, and product specifications to ensure completeness and compliance.
• Ensure documentation aligns with quality system requirements and regulatory expectations.
• Support change control activities and assess impact of proposed changes.
• Serve as a technical SME during internal and external audits.
• Support preparation of audit readiness activities and ensure technical documentation is inspection-ready.
• Partner with Regulatory Affairs, Quality, Marketing, Manufacturing, Medical Affairs and Operations to support business objectives.

Skills

Immunology

Flow cytometry

Assay development

Technical documentation

Project leadership

Communication

Education

Bachelor's degree in Life Science

Job description

Planet Pharma seeks a Scientist III to support sustainment and continuous improvement of reagent and assay products throughout their lifecycle. You will work with cross-functional teams to ensure documentation is robust and compliant while enabling development pipelines.

You bring a strong background in immunology and flow cytometry, with proven ability to lead projects, author technical files, and participate in audits to keep products inspection-ready.