Associate Director, Biomarker & Nonclinical Operations

Automatic Data Processing, Inc.

Watertown (MA)

On-site

USD 170,000 - 230,000

Full time

5 days ago

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Job summary

Seismic Therapeutic is seeking an Associate Director for Biomarker and Nonclinical Operations to lead bioanalytical and sample operations across CROs and laboratories. You will manage assay transfer, validation, and sample lifecycle while ensuring GLP and GCP compliance.

You will coordinate with Clinical Operations to protect sample quality and drive study timelines. The role requires extensive experience in biomarker workflows, sample management, and collaboration with cross-functional teams,

Qualifications

BS, MS or PhD in immunology, biochemistry, biology, or related field.
7+ years in biotech/pharma, CRO, or central lab.
Hands-on experience with ligand binding, mass spec, or cell-based assays.
Proven experience managing bioanalytical CROs, labs, or centers.
Familiarity with GLP and GCP requirements and data integrity.
Excellent written and verbal communication skills.

Responsibilities

Serve as operational lead for bioanalytical and biomarker CROs and labs.
Oversee transfer, optimization, validation of PK, immunogenicity, biomarker assays.
Review method validation plans, reports, and sample analysis for compliance.
Manage clinical and nonclinical sample processing at CROs and labs.
Maintain inventory, chain of custody, and long-term storage for samples.
Ensure GLP/GCP standards in the laboratory operations.