Scientist 1, Microbiology Development

MillenniumSoft Inc; San Diego (CA); On-site; USD 80,000 - 110,000; Full time

Job summary

MillenniumSoft Inc. is seeking a Scientist II, Reagent and Assay Development, to support sustainment and continuous improvement of reagent and assay products throughout their lifecycle, on site in San Diego, California.

You will coordinate with Regulatory Affairs, Quality, Marketing, Manufacturing, Medical Affairs and Operations to drive business objectives, prepare technical documentation, and ensure compliance with design controls and inspection readiness.

Qualifications

• Bachelor's degree in Life Science or equivalent required.
• Minimum 2 years in a research/biotech setting with relevant technologies.
• Strong understanding of immunology and cell-based assays.

Responsibilities

• Support reagent and assay sustainment projects for marketed products.
• Review and approve technical documentation for reagent and assay products.
• Review design history files, validation reports, risk assessments, and product specs.
• Ensure alignment with quality systems and regulatory expectations.
• Support change control activities and assess impacts of changes.
• Provide technical support during audits and readiness activities.
• Collaborate with Regulatory Affairs, Quality, Marketing, Manufacturing, Medical Affairs and Operations.

Skills

Immunology

Flow cytometry

Assay development

Technical documentation

Cross-functional collaboration

Communication

Education

Bachelor's degree in Life Science

Job description

Bill Rate ? On site

We value our talented employees, and whenever possible strive to help one of our associates grow professionally before recruiting new talent to our open positions.

Our people make all the difference in our success.

Scientist II, 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 II 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
• Provide technical support 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

Minimum Qualifications:

• Minimum of bachelor's degree in Life Science
• Minimum 2 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 collaborate effectively across functions
• Excellent written and verbal communication skills

Desired Qualifications:

• 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