Bioanalytical Scientist—ELISA/PK (GLP/GCP/CLIA)

Smithers - Medical Device Testing; Gaithersburg (MD); On-site; USD 70,000 - 85,000; Full time

Benefits offered by this job

Health insurance

Dental and vision plans

401K retirement plan

PTO

Job summary

Smithers PDS LLC in Gaithersburg, MD is seeking a Scientist to perform data analysis and immunoassays in GLP/GCP/CLIA compliant labs, supporting PK, biomarker, and immunogenicity studies.

The role is salaried and exempt, requiring 2+ years of immunological assay experience; responsibilities include method transfer/validation, data interpretation, and maintaining study records. Salary range: $70,000-$85,000 with comprehensive benefits.

Qualifications

• BA/BS in biology, life sciences, or chemistry with 2+ years of immunological assay experience.
• MS in biology, life sciences, or chemistry with at least 1 year of immunological assay experience.
• Experience with CROs and GLP, GCP, CLIA environments preferred.

Responsibilities

• Perform Ligand-binding assays (ELISA/MSD) for PK, Biomarker and Immunogenicity studies.
• Transfer, develop, validate, and test methods for GLP studies.
• Interpret data and provide summaries for studies.
• Maintain study records and raw data with data integrity.
• Ensure compliance with SOPs, safety and regulatory requirements.

Skills

Immunoassays

Data analysis

Laboratory techniques

MS Word

MS Excel

Education

BA/BS in biology or chemistry

MS in biology or life sciences

Tools

MS Word

MS Excel

Job description

Smithers PDS LLC in Gaithersburg, MD is seeking a Scientist to perform data analysis and immunoassays in GLP/GCP/CLIA compliant labs, supporting PK, biomarker, and immunogenicity studies.

The role is salaried and exempt, requiring 2+ years of immunological assay experience; responsibilities include method transfer/validation, data interpretation, and maintaining study records. Salary range: $70,000-$85,000 with comprehensive benefits.