Associate Scientist – Analytical Development & QC

Job – Associate Scientist – Analytical Development & QC

Location: New Haven, CT (100% onsite)

Duration: 12 Months (Possibility of extension)

Role Overview

This Associate Scientist III position is a key role within external analytical development and quality control (QC) team. The candidate will support analytical efforts throughout early- to late-stage clinical programs. This includes collaborating with internal and external QC laboratories and facilitating scientific data entry for assay performance trending.

Key Responsibilities

• Capture, verify, and standardize assay performance data across platforms to support method evaluation globally.
• Collaborate with laboratory teams to refine data pipelines, enhance metadata standards, and improve assay trending workflows.
• Produce clear summaries, dashboards, and reports for stakeholders; support SOP updates.
• Verify analytical data for assay performance and assist with analytical transfer/validation reports for late-stage clinical and commercial programs.
• Contribute to analytical method evaluation in the lab as needed.

Required Qualifications / Skills

• Hands-on experience in developing and executing analytical methods for biological products, preferably in a cGMP environment.
• Ability to critically evaluate 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 related to analytical testing, validation, and transfer.
• Strong organizational skills, attention to detail, creative thinking, and complex problem-solving abilities.
• Comfortable working in a lab with biological, infectious, and hazardous materials while using proper PPE.
• Physical capability to: lift/carry 15–30 pounds, work in controlled lab environments, gown/degown PPE, use computers, and communicate via phone/video/email.

Preferred Qualifications

• Bachelor’s or Master’s degree in Chemistry, Biochemistry, Molecular/Cell Biology, or related field.
• 3–6 years of experience in a relevant analytical laboratory setting.
• Experience with JMP, electronic documentation systems, and quality management systems.
• Strong hands-on experience in a cGMP environment.
• Comfortable working in a fast-paced team environment.
• High proficiency in MS Office: Word, Excel, Outlook, Visio, PowerPoint.