Associate Director, Biomarker and Nonclinical Operations

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Translational Sciences Full Time Employee Professional Watertown, Watertown, MA, US

Salary Range: $ To $ Annually

SEISMIC THERAPEUTIC

Associate Director, Biomarker and Nonclinical Operations

About Seismic

Seismic Therapeutic TM is a clinical-stage biotechnology company making a major shift in how immunology therapies are discovered and developed. The company has a growing preclinical stage best-in-class and first-in-class biologics pipeline, derived from its integrated IMPACT platform, to control dysregulated adaptive immunity and address multiple autoimmune diseases. The company is backed by a strong syndicate of life science investors and is located in the Boston area biotechnology hub.

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At our core, we are focused on phenomenal science, supportive culture, a superstar team, meritocracy, and patient-centric goals. Seismic has the tools, skills, ideas and people to make this a reality. Success will be the discovery and development of effective therapies for patients in need, and we invite you to become a part of that. This is a terrific opportunity for an experienced bioanalytical and biomarker operations professional to build the operational foundation for our assays and samples and join our small, dynamic and high-performing team.

Job Summary

Seismic is seeking a biomarker operations lead to ensure that the assays and samples behind our development decisions are managed with rigor, from the CRO laboratory to long-term storage. Reporting to the Senior Director, Biomarker and Translational Sciences, you will own the day-to-day execution of bioanalytical and biomarker work at CROs and specialty laboratories for Seismic's bioanalytical efforts and clinical studies, following Seismic's externalized operating model.

You will manage assay transfer and optimization at CROs, oversee method validation and sample analysis, and manage clinical and nonclinical samples throughout their lifecycle, both at our partners and in our own laboratory. You will also be accountable for ensuring that our laboratory operates to GLP and GCP standards.

Candidates should demonstrate ownership of bioanalytical and sample operations across multiple programs, including CRO selection and budgets, establishment of sample management systems and laboratory compliance programs.

Key Responsibilities

• Serve as the operational lead for bioanalytical and biomarker CROs and specialty laboratories, managing scopes of work, contracts, timelines, budgets, and accruals. Support vendor selection and qualification, track vendor performance, and participate in CRO audits with Quality. This will involve CRO calls in off hours.
• Manage the transfer of assays developed at Seismic to CROs, and partner with CRO scientists on the optimization, qualification, and validation of PK, immunogenicity, target engagement, and biomarker assays.
• Review key bioanalytical documents, including method validation plans and reports, bioanalytical and sample analysis plans, and sample analysis reports, to confirm that they are complete, accurate, and consistent with GLP, GCP, and current regulatory guidance.
• Oversee clinical sample processing and analysis at CROs and central laboratories, including collection and processing requirements, laboratory manuals, kits, shipments, and resolution of sample queries. Partner with Clinical Operations so that site procedures protect sample quality.
• Own Seismic's sample management across the sample lifecycle, maintaining a complete and current…