Scientist 2, Biology

A-Line Staffing Solutions; Milpitas (CA); On-site; USD 62,000 - 89,000; Full time

Job summary

A-Line Staffing Solutions LLC in Milpitas, CA is seeking a Senior Scientist – Assay Development & Quality to advance immunology, flow cytometry, and assay development within a regulated quality framework. This on-site role focuses on documentation, audits, and cross-functional collaboration.

You will review technical files, support change control, and partner with Regulatory Affairs, Quality, Manufacturing, and Medical Affairs to ensure product quality from development through lifecycle.

Qualifications

• Bachelor's degree in Life Sciences or related field.
• 5+ years of experience in scientific research, clinical or diagnostic laboratory, pharma R&D, or biotech.
• Strong understanding of immunology, flow cytometry, and assay development.
• Experience authoring, reviewing, and maintaining technical documentation.
• Ability to lead projects independently and collaborate across teams.
• Excellent written and verbal communication; detail-oriented and compliant.

Responsibilities

• Support sustainment and continuous improvement projects for marketed reagent and assay products.
• Review and approve technical documentation for accuracy and compliance.
• Evaluate design history files, validation reports, risk assessments, and product specs.
• Ensure documentation meets quality system and regulatory expectations.
• Support change control activities and assess impact of product changes.
• Act as SME during audits and support audit readiness.
• Collaborate with Regulatory, Quality, Marketing, Manufacturing, Medical Affairs, and Operations.
• Contribute to product quality and lifecycle improvements.

Skills

Immunology

Flow cytometry

Assay development

Technical documentation

Project leadership

Written and verbal communication

Education

Bachelor's degree in Life Sciences

Job description

Senior Scientist – Assay Development & Quality

Location: Milpitas, CA | Work Arrangement: On-site | Pay Rate: $54.95 per hour

Make an Impact in Biotechnology and Scientific Innovation! Are you an experienced scientist ready to take your expertise in immunology, flow cytometry, and assay development to the next level? Join a team focused on advancing innovative life sciences technologies that help uncover new insights in biology and medicine.

Why Consider This Opportunity?

• Competitive compensation: Earn $54.95 per hour.
• Innovative environment: Contribute to technologies supporting scientific research and clinical applications.
• Meaningful responsibilities: Help maintain the quality, reliability, and compliance of scientific products.
• Cross-functional exposure: Collaborate with experts across Quality, Regulatory Affairs, Manufacturing, Medical Affairs, Marketing, and Operations.
• Use your expertise: Apply your knowledge of assay technologies, scientific documentation, and product quality to real-world challenges.

What You'll Do

Support sustainment and continuous improvement projects for marketed reagent and assay products. Review and approve technical documentation to ensure accuracy, completeness, and compliance. Evaluate design history files, validation reports, risk assessments, technical files, and product specifications. Ensure documentation meets applicable quality system requirements and regulatory expectations. Support change control activities and evaluate the impact of proposed product, process, and documentation changes. Serve as a technical subject matter expert during internal and external audits. Support audit preparation and ensure technical documentation is accurate and inspection-ready. Partner with Regulatory Affairs, Quality, Marketing, Manufacturing, Medical Affairs, and Operations teams to support product and business objectives. Contribute to product quality and continuous improvement throughout the product lifecycle.

What You'll Bring

• Bachelor's degree in Life Sciences or a related scientific discipline.
• At least 5 years of relevant experience in scientific research, a clinical or diagnostic laboratory, pharmaceutical R&D, or biotechnology.
• Strong understanding of immunology, flow cytometry, assay development, or related cell-based research technologies.
• Experience authoring, reviewing, and maintaining technical documentation.
• Ability to lead projects independently and collaborate effectively across functional teams.
• Excellent written and verbal communication skills.
• Strong attention to detail and the ability to evaluate technical information for accuracy and compliance.

Preferred Qualifications

• Experience with flow cytometry-based diagnostic products.
• Background in reagent and assay development.
• Experience supporting regulatory inspections, quality audits, and audit readiness.
• Familiarity with design controls, risk management, verification and validation, and change control processes.
• Knowledge of immunology, cancer biology, and cell biology.
• Experience with product lifecycle management.

Ready for Your Next Scientific Opportunity?

Bring your scientific knowledge and technical expertise to a role at the intersection of biotechnology, product quality, and regulatory compliance.