Scientist 2, Biology

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 need for a Scientist 2, Biology for a 12+ month onsite contract in San Diego, CA. The role focuses on reagent and assay sustainment, documentation review, and cross-functional collaboration to support regulatory and quality objectives.

The ideal candidate holds a Life Science bachelor’s degree and at least 5 years in a research or biotech setting, with strong immunology and flow cytometry and proven technical writing skills.

Qualifications

• Bachelor’s degree in Life Science.
• Minimum 5 years of related experience in a research setting, clinical/diagnostic laboratory, or pharmaceutical/biotechnology R&D.
• 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 across functions.

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, and product specifications.
• Ensure documentation aligns with quality system requirements and regulatory expectations.
• Support change control activities and assess impact of changes.
• Serve as a technical SME during internal and external audits.
• Support audit readiness activities and ensure documentation is inspection-ready.
• Partner with Regulatory Affairs, Quality, Marketing, Manufacturing, Medical Affairs and Operations teams.

Skills

Flow cytometry

Immunology

Reagent and assay development

Technical documentation

Education

Bachelor's degree in Life Science

Job description

Immediate need for a talented Scientist 2, Biology. This is a 12+ months contract opportunity with long-term potential and is located in San Diego, CA(Onsite).

Job ID: 26-28282

Pay Range: $50/hr - $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


• 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

Key Requirements and Technology Experience:

• Key skills; Flow cytometry, Immunology, reagent and assay development, technical documentation


• 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


• 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

Our client is a leading Healthcare 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.