Clinical Bioanalytical Scientist, mRNA Cell Therapies

ACTalent; Frederick (MD); On-site; USD 66,000 - 80,000; Full time

Benefits offered by this job

Medical, dental & vision

401(k) Retirement Plan

Paid time off

On-site lab facilities

Job summary

Actalent is seeking a Scientist / Associate Scientist for Clinical Bioanalytical Testing in Frederick, MD. The role focuses on hands-on molecular, cellular, and immunological assays to support PK, PD, and biomarker analyses in autoimmune disease programs.

The candidate will perform qPCR/dPCR, contribute to assay qualification and validation, and maintain compliant lab records in a GLP/GCP environment. On-site, five days a week, with opportunities to advance in a fast-paced biotech setting.

Qualifications

• Bachelors degree with at least 4 years or Masters with at least 2 years in molecular biology, biochemistry, immunology, or related field.
• At least 2 years in pharma/biotech/clinical lab.
• Hands-on qPCR and/or dPCR experience.
• Experience in regulated labs (GCP/GLP/GMP/CLIA) and contamination control.

Responsibilities

• Perform clinical bioanalytical testing using molecular techniques, including qPCR and/or digital PCR, to support PK, PD, and biomarker analyses.
• Execute established molecular, flow cytometry, and cell-based assays that support pharmacology and biomarker assessments for mRNA cell therapy programs.
• Support analytical method qualification and validation through experimental execution, data collection, analysis, and documentation.
• Follow contamination prevention and control procedures for nucleic acid amplification assays to ensure reliability.
• Process clinical samples, including preparation, testing, storage, tracking, and biobanking.
• Maintain accurate, complete, and compliant laboratory records per GCP/GLP/GMP and SOPs.

Skills

Molecular biology

Biochemistry

Immunology

Cell-based assays

GCP knowledge

GLP/GMP/CLIA

Attention to detail

Data integrity

Team collaboration

Education

B.S./Bachelors in Molecular Biology

M.S. in related field

Tools

qPCR

dPCR/ddPCR

ELN

LIMS

Flow cytometry

Job description

Actalent is seeking a Scientist / Associate Scientist for Clinical Bioanalytical Testing in Frederick, MD. The role focuses on hands-on molecular, cellular, and immunological assays to support PK, PD, and biomarker analyses in autoimmune disease programs.

The candidate will perform qPCR/dPCR, contribute to assay qualification and validation, and maintain compliant lab records in a GLP/GCP environment. On-site, five days a week, with opportunities to advance in a fast-paced biotech setting.