Scientist II - Reagents and Assay Development

Pyramid Consulting, Inc; San Diego (CA); On-site; USD 69,000 - 73,000; Full time

Benefits offered by this job

Health insurance

401(k) plan

Paid sick leave

Job summary

Pyramid Consulting, Inc. has an immediate opening for a Scientist II - Reagents and Assay Development in San Diego, onsite.

This 6+ month contract offers hands-on work in Life Sciences R&D, focusing on reagent and assay development and supporting regulatory inspections and quality audits. The role requires 5+ years of experience in immunology, flow cytometry, or related cell-based research technologies, with a BS in Life Science.

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.
• 5+ years of experience in Life Sciences R&D, with hands-on experience in reagent development, assay development, immunology, or flow cytometry.
• Bachelor's degree in Life Science.
• 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.

Responsibilities

• Support reagent and assay sustainment projects for marketed products
• Review and approve technical documentation to support reagent and assay products
• 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
• Partner with Regulatory Affairs, Quality, Marketing, Manufacturing, Medical Affairs, and Operations teams to support business objectives

Skills

Flow cytometry

Regulatory inspections

Design controls

Risk management

Verification/validation

Change control

Immunology knowledge

Cancer biology

Cell biology

Reagent development

Assay development

Product lifecycle management

Technical documentation

Project leadership

Cross-functional collaboration

Communication skills

Education

Bachelor's degree in Life Science

Job description

Immediate need for a talented Scientist II - Reagents and Assay Development. This is a 06+months contract opportunity with long-term potential and is located in San Diego ,CA(Onsite).

Job ID:26-33793

Pay Range: $50 - $53/hour. Employee benefits include, but are not limited to, health insurance (medical, dental, vision), 401(k) plan, and paid sick leave (depending on work location).

Key Responsibilities:

• Support reagent and assay sustainment projects for marketed products
• Review and approve technical documentation to support reagent and assay products
• 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
• Partner with Regulatory Affairs, Quality, Marketing, Manufacturing, Medical Affairs, and Operations teams to support business objectives

Key Requirements and Technology Experience:

• 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
• 5+ years of experience in Life Sciences R&D, with hands-on experience in reagent development, assay development, immunology, or flow cytometry
• Bachelor's degree in Life Science
• 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

Our client is a leading Medical Equipment Manufacturing Industry, and we are currently interviewing to fill this and other similar contract positions.

Pyramid Consulting, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

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