Senior QC Method & Data Analyst (Cell Therapy)

RoslinCT; Hopkinton (MA); On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

Educational Assistance

401(k)

Job summary

RoslinCT seeks a Quality Control Technical Services Senior Analyst (Contractor) to lead analytical method lifecycle activities in a cGMP cell therapy environment. You will write SOPs, develop test methods, and support method transfers, validations, and stability studies while ensuring compliant documentation.

You will work with QC and QA to ensure timely analytics, participate in stability testing, and contribute to a fast-paced manufacturing operation on-site in Hopkinton, MA.

Qualifications

• Bachelor’s degree in a scientific discipline required.
• 5+ years of analytical laboratory experience in a cGMP QC setting.
• Experience with qPCR, Flow Cytometry, ELISA, or cell-based assays.
• Knowledge of analytical method lifecycle, ICH guidelines.
• Excellent written and verbal communication; strong troubleshooting.

Responsibilities

• Write/review SOPs and test methods for analytical methods lifecycle.
• Support method transfer, qualification, validation, and stability studies.
• Collaborate with QC and QA to ensure GMP documentation and right-first-time results.
• Support data compilation and routine QC testing for reporting to partners.
• Assist in scheduling and monitoring QCTS activities and stability studies.

Skills

Analytical lab work

cGMP QC

qPCR

Flow Cytometry

ELISA

Cell-based assays

ICH guidelines

Troubleshooting

Prioritization

Team collaboration

Education

Bachelor’s degree in scientific discipline

Job description

RoslinCT seeks a Quality Control Technical Services Senior Analyst (Contractor) to lead analytical method lifecycle activities in a cGMP cell therapy environment. You will write SOPs, develop test methods, and support method transfers, validations, and stability studies while ensuring compliant documentation.

You will work with QC and QA to ensure timely analytics, participate in stability testing, and contribute to a fast-paced manufacturing operation on-site in Hopkinton, MA.