Job Description
KAYGEN is an emerging leader in providing top talent for technology-based staffing services. We specialize in providing high-volume contingent staffing, direct hire staffing and project-based solutions to companies worldwide ranging from startups to Fortune 500 and Managed Service Providers (MSP) across a wide variety of industries.
JOB DESCRIPTION:
Position: Scientist 2, Biology/Scientist III, Reagent and Assay Development
Location: Milpitas, CA 95035
Duration: 12 months with possible extension
TECHNICAL SKILLS:
Must Have:
- Minimum of bachelor’s degree in Life Science
- Minimum 5 years of related experience in a research setting, clinical/diagnostic laboratory, or pharmaceutical/biotechnology 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 effectively across functions
- Excellent written and verbal communication skills
Nice To Have:
- Experience with flow cytometry-based diagnostic products
- Experience supporting regulatory inspections and quality audits
- Familiarity with design controls, risk management, verification/validation, and change control processes
- Strong immunology, cancer biology and cell biology knowledge
- Experience in reagent and assay development
- Experience with product lifecycle management
Scientist III, Reagent and Assay Development
- The Reagent & Assay Development Group focuses on providing differentiated reagent solutions that uncover truths in biology and medicine.
- Teams of hardworking scientists are responsible for initiating and driving the reagent and assay development projects and integrating assays and flow cytometry instruments to create the next generation of research and clinical Flow Cytometry platforms.
- Products include cell analyzers, cell sorters, reagents, assays and software.
- The Scientist III is responsible for supporting the sustainment and continuous improvement of reagent and assay products throughout their lifecycle.
Primary 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 applicable quality system requirements and regulatory expectations
- Support change control activities and assess the impact of proposed product, process, or documentation changes
- Serve as a technical subject matter expert 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 Operation teams to support business objectives
Shift: ['• Minimum of bachelor’s degree in Life Science • Minimum 5 years of related experience in a research setting, clinical/diagnostic laboratory, or pharmaceutical/biotechnology 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 effectively across functions • Excellent written and verbal communication skills']
Start: ['• Experience with flow cytometry-based diagnostic products • Experience supporting regulatory inspections and quality audits • Familiarity with design controls, risk management, verification/validation, and change control processes • Strong immunology, cancer biology and cell biology knowledge • Experience in reagent and assay development • Experience with product lifecycle management']
At KAYGEN, people are at the heart of everything we do. We foster a diverse, inclusive, and employee-driven culture where every individual is valued, empowered, and encouraged to bring their authentic self to work. Our candidate-first approach means we are committed to understanding your career goals and connecting you with opportunities that align with your aspirations, skills, and potential. Whether you're taking the next step in your career or searching for your dream opportunity, KAYGEN is more than a staffing partner—we're a community dedicated to helping you grow, succeed, and thrive. Join us and discover a place where your talent is recognized, your ambitions are supported, and your future is built alongside a team that invests in your success every step of the way.
Our team of experienced staffing experts will work with you to find you the best opportunity. For more information, please visit us at www.kaygen.com.
Benefits:
- Free Healthcare Insurance
- 401(k) Retirement Plan
- Free Life Insurance
- Sick Time Off
- Mentorship Program
- Certifications
- Referrals
- Family and Wellness benefits
- Continuous Growth and Career Development
Numbers & Facts
| Location | Milpitas, CA |
| Job Type | Temporary, Contractor, Full-time |
| Industry | Computer/IT Services |
| Salary | $50–$62 Per Hour |
| Company Size | 100 to 499 employees |
| Year Founded | 2003 |
| Website | http://www.kaygen.com |
Benefits
Paid Sick Days, Professional Development, 401K, Employee Referral Program, Flexible Spending Accounts, Employee Events, Life Insurance, Merchandise Discounts
About Company
Kaygen, an award-winning technology consulting and talent firm, assists organizations to achieve digital transformation. From structuring data to the Cloud and visualization, Kaygen leads the digital transformation of global clients.
Kaygen, from the Japanese word, kaizen, for continuous improvement, signifies how we continuously seek to bring expert tech talent to our client engagements to create a sustainable competitive advantage. However, there is more. Our company is diverse, and minority woman owned and operated by expert data technologists who have conceived and developed the very strategic technology initiatives that we now engage in for our clients with our talent.
Our core belief in diversity, complemented by the principles of kaizen, ensures we bring the best expert data talent to work transparently, collaboratively, and with the flexibility to ensure client success.
Visit http://www.kaygen.com/ for a solutions overview.
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Skills
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