Analytical Development Scientist - Biologics QC

Pharmaceutical Company; New Haven (CT); On-site; USD 90,000 - 115,000; Full time

Job summary

Pharmaceutical Company in New Haven, CT, is seeking an Associate Scientist III – Analytical Development & Quality Control to support analytical development and QC activities for biological products across early- to late-stage clinical programs.

The role collaborates with internal and external QC labs to ensure assay performance, data verification, trending, method transfer/validation, and quality-system activities in a cGMP environment.

Qualifications

• Bachelor's or Master's in Chemistry, Biochemistry, Molecular Biology, or related field.
• 3–6+ years of analytical lab experience.
• Experience with biological products/biologics preferred.
• Strong knowledge of cGMP for analytical testing, validation, and transfer.

Responsibilities

• Capture, verify, and analyze assay performance data across platforms.
• Support method performance evaluation, trending, and improvements.
• Coordinate with internal/external labs for testing and data issues.
• Assist transfer and validation of analytical methods for programs.
• Review documentation, data, protocols, and validation reports.
• Support quality investigations and close quality records.
• Prepare summaries, reports, and dashboards for stakeholders.
• Contribute to SOP updates and lab documentation.

Skills

Analytical lab experience

Data analysis

Method validation

Documentation

Cross-functional collaboration

Education

Bachelor's or Master's in Chemistry/Biochemistry/Molecular Biology/Cell Biology

Tools

JMP

Excel

Visio

PowerPoint

Quality Management Systems

Job description

Pharmaceutical Company in New Haven, CT, is seeking an Associate Scientist III – Analytical Development & Quality Control to support analytical development and QC activities for biological products across early- to late-stage clinical programs.

The role collaborates with internal and external QC labs to ensure assay performance, data verification, trending, method transfer/validation, and quality-system activities in a cGMP environment.