Principal Scientist Immunoassay

Resolian • Malvern, AR

7d

About The Position

Responsibilities · Direct studies from multiple clients from method development through validation and sample analysis · Scientific lead on assigned projects to ensure proper methodology, technique, and compliance with GLP/GCP · Schedule resources, set up experiments, review and table data, and write reports as needed · Communicate progress and status to Management · Participate in client and regulatory audits · Archive study related items · Collaborate with Project Manager and support teams to ensure client timelines are met · Work with clients to understand project needs and create successful partnership · Familiar with regulatory requirements; GLP, GCP, OECD, 21CFR Part 11 · Record tasks in accordance with Good Documentation Practices (GDP) · Escalate data integrity and client concerns to Management · Participate and review template and SOP updates · Follow applicable SOPs and procedural documents · Act as the Principal Investigator for clinical studies · Other tasks as assigned

Requirements

• BA/BS or higher with 1-3 years Principal Scientist experience; all experiences will be evaluated
• Knowledge and understanding of regulatory requirements; GLP, GCP, 21CFR Part 11, GDP, GMP
• Able to work in a regulated environment
• Able to work effectively and contribute within a team
• Able to work with computer systems
• Able to document clearly
• Able to communicate clearly
• Knowledge of and experience in a regulatory environment

Responsibilities

• Direct studies from multiple clients from method development through validation and sample analysis
• Scientific lead on assigned projects to ensure proper methodology, technique, and compliance with GLP/GCP
• Schedule resources, set up experiments, review and table data, and write reports as needed
• Communicate progress and status to Management
• Participate in client and regulatory audits
• Archive study related items
• Collaborate with Project Manager and support teams to ensure client timelines are met
• Work with clients to understand project needs and create successful partnership
• Familiar with regulatory requirements; GLP, GCP, OECD, 21CFR Part 11
• Record tasks in accordance with Good Documentation Practices (GDP)
• Escalate data integrity and client concerns to Management
• Participate and review template and SOP updates
• Follow applicable SOPs and procedural documents
• Act as the Principal Investigator for clinical studies
• Other tasks as assigned

What This Job Offers

• Job Type: Full-time
• Career Level: Principal
• Number of Employees: 251-500 employees