Associate Scientist – Analytical Development

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

We are seeking an Associate Scientist III – Analytical Development & Quality Control to support analytical development and quality control activities for biological products across early- to late-stage clinical programs.

This role will work closely with internal and external QC laboratories to support analytical method performance, data verification, assay trending, method transfer/validation, and quality-system activities. The ideal candidate will have hands‑on analytical laboratory experience in a cGMP environment, strong attention to detail, and the ability to collaborate effectively across scientific and quality teams.

Key Responsibilities

• Capture, verify, standardize, and analyze assay performance data across multiple analytical platforms.
• Support analytical method performance evaluation, trending, and continuous improvement activities.
• Partner with internal and external laboratories to monitor testing and resolve analytical data or workflow issues.
• Support analytical method transfer and validation activities for clinical and commercial programs.
• Review scientific documentation, analytical data, protocols, and validation reports for accuracy and completeness.
• Support quality investigations and timely closure of quality records within established quality systems.
• Prepare clear summaries, reports, and dashboards for cross‑functional stakeholders.
• Contribute to SOP updates, process improvements, and laboratory documentation.

Required Qualifications

• Bachelor's or Master's degree in Chemistry, Biochemistry, Molecular Biology, Cell Biology, or a related scientific discipline.
• 3–6+ years of relevant analytical laboratory experience.
• Hands‑on experience with analytical methods for biological products/biologics preferred.
• Strong understanding of cGMP requirements related to analytical testing, method validation, and method transfer.
• Strong scientific documentation, data review, and analytical problem‑solving skills.
• Excellent written and verbal communication skills.
• Ability to work effectively in cross‑functional and fast‑paced environments.
• Strong organizational skills and attention to detail.

Preferred Skills

• Experience with JMP or similar statistical/data‑analysis software.
• Experience with electronic documentation and quality management systems.
• Experience supporting external QC laboratories or CROs.
• Strong Microsoft Office skills, particularly Excel, Word, PowerPoint, Outlook, and Visio.
• Experience with assay performance trending and analytical data visualization.