Bioanalytical Scientist – Immunoassays & GLP/GCP

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

Benefits offered by this job

Health insurance

Dental plan

Vision plan

401K retirement plan

PTO

Job summary

Smithers PDS LLC (Pharmaceutical Development Services) seeks a Scientist to join our Gaithersburg, MD team. The role centers on data analysis and performing assays in accordance with SOPs while meeting GLP, GCP, and CLIA requirements.

The incumbent will help ensure the lab, materials, and equipment are properly maintained and compliant. This exempt, salaried position typically expects 40+ hours, with extended hours as needed to meet client deliverable commitments.

Qualifications

• Experience with ligand-binding assays used in PK, biomarker and immunogenicity studies.
• Proficient data analysis and data interpretation for GLP studies.
• Familiarity with regulatory requirements (GLP, GCP, CLIA).

Responsibilities

• Perform analysis including method transfer, development, validation and sample testing for GLP studies.
• Provide data summaries and interpretations for studies.
• Maintain lab materials and equipment and ensure safe operation and compliance.
• Review data generated by team members and support cross-department initiatives.
• Work independently and in a team-oriented environment to meet client deliverables.

Skills

Ligand-binding assays

ELISA/MSD

Data analysis

GLP/GCP/CLIA knowledge

Watson LIMS

Education

BA/BS in biology, life sciences, or chemistry

MS in biology, life sciences, or chemistry

Tools

Watson LIMS

Job description

Smithers PDS LLC (Pharmaceutical Development Services) seeks a Scientist to join our Gaithersburg, MD team. The role centers on data analysis and performing assays in accordance with SOPs while meeting GLP, GCP, and CLIA requirements.

The incumbent will help ensure the lab, materials, and equipment are properly maintained and compliant. This exempt, salaried position typically expects 40+ hours, with extended hours as needed to meet client deliverable commitments.