Senior QC Analyst - Analytical Methods for Cell Therapy

RoslinCT US; Hopkinton (MA); On-site; USD 85,000 - 125,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k) program

Educational assistance

Job summary

RoslinCT US is seeking a Quality Control Technical Services Senior Analyst - Contractor to support optimization, qualification, transfer, and verification of analytical methods for cGMP cell therapy production.

The role involves writing SOPs, test methods, and data capture forms; supporting analytical method lifecycle activities; and coordinating analytical method and stability study executions with QC/QA. On-site 8:00AM–5:00PM schedule with potential flexible shifts.

Qualifications

• Bachelor’s degree in scientific discipline required.
• Minimum 5+ years of analytical laboratory experience.
• Experience in a cGMP QC laboratory environment.
• Familiarity with analytical method lifecycle guidances (e.g., ICH).
• Experience with qPCR, Flow Cytometry, ELISA and/or cell-based assays.
• Excellent written and verbal communication skills.
• Strong troubleshooting and problem-solving abilities.
• Ability to prioritize multiple projects and meet timelines in a team setting.

Responsibilities

• Write and/or review SOPs in support of method lifecycle and stability programs.
• Write and/or review test methods and data capture forms.
• Review protocols and reports for analytical methods and stability studies.
• Support analytical method executions including transfer, qualification, validation, and verification.
• Collaborate with QC/QA to compile method and stability study data with accuracy.

Skills

Analytical laboratory experience

cGMP QC laboratory environment

Written and verbal communications

Prioritization of objectives

Team-oriented and collaborative

Fast-paced environment adaptability

Education

Bachelor’s degree in scientific discipline

Tools

qPCR

Flow Cytometry

ELISA

Cell-based assays

Job description

RoslinCT US is seeking a Quality Control Technical Services Senior Analyst - Contractor to support optimization, qualification, transfer, and verification of analytical methods for cGMP cell therapy production.

The role involves writing SOPs, test methods, and data capture forms; supporting analytical method lifecycle activities; and coordinating analytical method and stability study executions with QC/QA. On-site 8:00AM–5:00PM schedule with potential flexible shifts.