Biomarker & Nonclinical Operations Director

Seismic Therapeutic; Watertown (MA); On-site; USD 170,000 - 230,000; Full time

Job summary

Seismic Therapeutic, a clinical-stage biotechnology company in the Boston area, seeks an Associate Director of Biomarker and Nonclinical Operations to lead bioanalytical and sample operations from CROs to internal labs. You will ensure GLP/GCP compliance, manage assay transfers, and oversee lifecycle management of clinical and nonclinical samples.

The role requires 7+ years in biomarker operations or related bioanalytical settings, with strong vendor management and cross-functional collaboration

Qualifications

• 7+ years in biotech/pharma with biomarker operations or bioanalytical lab experience.
• Proven experience managing bioanalytical CROs, central laboratories, or specialty laboratories.
• Experience with GLP and GCP requirements and data integrity expectations.

Responsibilities

• Serve as the operational lead for bioanalytical and biomarker CROs and laboratories, managing scopes of work, contracts, timelines, budgets, and accruals.
• Manage transfer of assays to CROs and partner on optimization, qualification, and validation of PK, immunogenicity, and biomarker assays.
• Oversee clinical and nonclinical sample processing and analysis at CROs and central laboratories, ensuring adherence to GLP and GCP standards.
• Own sample management lifecycle across CROs, vendors, and in-house lab, including chain of custody and final disposition.

Skills

Bioanalytical operations

CRO/vendor management

GLP/GCP compliance

Sample management

Team coordination

Education

BS/MS/PhD in immunology or related field

Tools

LIMS

Job description

Seismic Therapeutic, a clinical-stage biotechnology company in the Boston area, seeks an Associate Director of Biomarker and Nonclinical Operations to lead bioanalytical and sample operations from CROs to internal labs. You will ensure GLP/GCP compliance, manage assay transfers, and oversee lifecycle management of clinical and nonclinical samples.

The role requires 7+ years in biomarker operations or related bioanalytical settings, with strong vendor management and cross-functional collaboration