QC Chemist I: Biotech Lab, GMP & Analytical Methods

Lancesoft; Frederick (MD); On-site; USD 60,000 - 90,000; Full time

Job summary

Lancesoft is seeking an onsite QC Analyst in Frederick, MD to perform testing of raw materials, intermediates and final products using cell-based bioassays, flow cytometry, ELISA, and qPCR. You will assist with data trending, routine review of test data, and support product release documentation.

The role requires strong GMP knowledge, SOP familiarity, and the ability to communicate with scientific staff. A relevant degree with work experience and proficiency in MS Office is expected.

Qualifications

• Bachelor's Degree or AA Degree with 2+ years in biotech/Quality Control (QC).
• Or High School Diploma with 3+ years in biotech/ QC.
• Strong GMP, SOP and QC process knowledge is preferred.

Responsibilities

• Perform testing of raw materials, intermediates and final products using cell-based bioassays, Flow Cytometry, ELISA and qPCR.
• Support data trending and routine review of test data and related docs for in-process, drug substance and drug product release.
• Contribute to generation of CoAs and maintain lab instruments for calibration and maintenance.
• Author or revise SOPs, qualification/validation protocols and reports.
• Assist investigations of out-of-specification results and discuss root causes in meetings.

Skills

GMP knowledge

SOP familiarity

Quality control

Cell-based assays

Flow cytometry

ELISA

qPCR

Data trending

Documentation

Education

Bachelor's Degree

AA Degree + 2+ years experience

High School Degree + 3+ years experience

Tools

MS Word

Excel

PowerPoint

Job description

Lancesoft is seeking an onsite QC Analyst in Frederick, MD to perform testing of raw materials, intermediates and final products using cell-based bioassays, flow cytometry, ELISA, and qPCR. You will assist with data trending, routine review of test data, and support product release documentation.

The role requires strong GMP knowledge, SOP familiarity, and the ability to communicate with scientific staff. A relevant degree with work experience and proficiency in MS Office is expected.