Senior Associate Scientist, Analytical Development and Quality Control

About the role

This Associate Scientist III (Contractor) will be a key team member in the client’s external analytical development and quality control team, supporting analytical efforts from early-stage through late-stage clinical programs.

The position involves working closely with internal and external QC laboratories to facilitate scientific data entry for assay performance trending, support external testing oversight, and ensure laboratory investigation closure within the quality system.

Responsibilities

• Accurately capture, verify, and standardize assay performance data across platforms to support method performance evaluation across a global testing network.
• Interface with laboratory teams, refine data pipelines, enhance metadata standards, and drive continuous improvements in assay trending workflows.
• Produce clear summaries, dashboards, and periodic reports for stakeholders, and support SOP updates.
• Support analytical data verification for assay performance and analytical transfer/validation reports for late-stage clinical and commercial programs.
• Support external QC testing oversight with timely communication and closure of quality records within the quality system.

Requirements

• Bachelor’s or Master’s degree in Chemistry, Biochemistry, Molecular and Cell Biology, or a related discipline.
• 3–6+ years of experience working in a relevant analytical laboratory setting.
• Strong hands-on experience in the development and execution of analytical methods for biological products, especially in a cGMP environment (a significant plus).
• Ability to conduct critical evaluation of scientific documentation and testing data.
• Excellent written and verbal communication skills.
• Strong collaboration skills and experience working in cross-functional teams.
• Familiarity with cGMP regulations pertaining to analytical testing, validation, and transfer, and expertise in analytical laboratories.
• Excellent organizational skills, attention to detail, creative thinking, and complex problem-solving abilities.
• Ability to work comfortably in a controlled environment with biological, infectious, and hazardous materials under PPE.

The duties of this role are generally conducted in a lab environment. Employees must be able, with or without accommodation, to: lift/carry 15/30 pounds unassisted/assisted; gown/degown PPE; use a computer; engage in communications via phone, video, and electronic messaging; engage in problem-solving and non-linear thought, analysis, and dialogue; collaborate with others; and maintain general availability during standard business hours.

Preferred Qualifications

• Experience with JMP, electronic documentation, and quality management systems.
• Strong hands-on experience in a cGMP environment.
• Experience working in a fast-paced team environment.
• High proficiency in MS Office software, including Word, Excel, Outlook, Visio, and PowerPoint.