Scientist 2, Biology

A-Line Staffing Solutions LLC; San Diego (CA); Vor Ort; USD 62.000 - 89.000; Vollzeit

Zusammenfassung

A-Line Staffing Solutions LLC is seeking a Senior Scientist – Assay Development & Quality in San Diego, CA to support reagent and assay product sustainment, technical documentation, and quality compliance. This role emphasizes cross-functional collaboration across Research, Quality, Regulatory Affairs, Manufacturing, Medical Affairs, and Operations.

The candidate should have a life sciences background with 5+ years of relevant experience, strong immunology and flow cytometry knowledge, and a

Qualifikationen

• Bachelor's degree in Life Sciences or a related field.
• 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 and leading cross-functional projects.

Aufgaben

• 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 technical documentation aligns with applicable quality system requirements and regulatory expectations.
• Support change control activities and assess 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.
• Collaborate with Regulatory Affairs, Quality, Marketing, Manufacturing, Medical Affairs, and Operations teams to support business objectives.

Kenntnisse

Immunology

Flow cytometry

Assay development

Ausbildung

Bachelor's degree in Life Sciences or related field

Jobbeschreibung

Senior Scientist – Assay Development & Quality

Location: San Diego, CA

Pay Rate: $54.95 per hour

Advance Your Scientific Career in Biotechnology! Are you an experienced scientist with a background in immunology, flow cytometry, assay development, or biotechnology? Take the next step in your career with an opportunity to apply your scientific expertise to innovative life sciences products that support research, diagnostics, and medical advancements. We are seeking a Senior Scientist – Assay Development & Quality to support reagent and assay product sustainment, technical documentation, quality compliance, and continuous improvement. This role is ideal for a detail-oriented scientific professional who enjoys solving complex problems, evaluating technical data, and collaborating with cross-functional teams to maintain high-quality products throughout their lifecycle.

Why You'll Want to Consider This Opportunity

• Competitive pay: Earn $54.95 per hour.
• Innovative science: Contribute to technologies supporting biological research and diagnostic applications.
• Meaningful work: Help ensure the quality, reliability, and compliance of scientific products.
• Cross-functional collaboration: Partner with experts in Research, Quality, Regulatory Affairs, Manufacturing, Medical Affairs, and Operations.
• Professional growth: Apply your scientific knowledge to product lifecycle management, technical review, and continuous improvement initiatives.

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 technical documentation aligns with applicable quality system requirements and regulatory expectations.
• Support change control activities and assess 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.
• Collaborate with Regulatory Affairs, Quality, Marketing, Manufacturing, Medical Affairs, and Operations teams to support 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 while collaborating effectively with cross-functional teams.
• Excellent written and verbal communication skills.
• Strong attention to detail and the ability to assess technical information for completeness, 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, or cell biology.
• Experience with product lifecycle management.

Take the Next Step in Your Scientific Career

Bring your scientific expertise to a role that combines biotechnology, technical documentation, product quality, and cross-functional collaboration.