Biomarker & Biospecimen Operations Lead (Hybrid)

Candel Therapeutics; Needham (MA); Hybrid; USD 161,000 - 175,000; Full time

Job summary

Candel Therapeutics is seeking a Manager/Senior Manager, Biomarker & Biospecimen Operations to oversee biospecimen collection, tracking, shipment, reconciliation, vendor management, and biomarker logistics across clinical programs. You will partner with Translational Medicine, Clinical Ops, Data Management, and QA to ensure high-quality, compliant biospecimen operations throughout trials.

This role focuses on chain-of-custody, data reconciliation, lab oversight, and vendor governance to support

Qualifications

• Bachelor’s degree in Biology, Life Sciences, Clinical Laboratory Science, Biomedical Sciences, or related field.
• 5+ years of relevant experience for Manager level or 8+ years for Senior Manager level in biotech, pharma, CRO, or clinical research.
• Direct experience with clinical trial biospecimens and biomarker/translational teams.
• Experience setting up central/specialty labs and external vendors.
• Knowledge of ICH-GCP and biospecimen best practices.

Responsibilities

• Lead biospecimen collection, processing, shipment, inventory, reconciliation, and storage across studies.
• Develop biospecimen management plans, manuals, schedules, and SOPs.
• Coordinate courier/logistics and biospecimen site activities with Clinical Ops.
• Oversee labs, CROs, vendors, and SOWs, ensuring quality and compliance.
• Ensure chain of custody, data reconciliation with EDC, and traceability.
• Maintain inspection-ready documentation and support audits and CAPAs.

Skills

Project management

Organizational skills

Problem solving

Written communication

Verbal communication

Excel proficiency

Education

Bachelor's degree in Biology or related field

Tools

Data tracking tools

Excel

Job description

Candel Therapeutics is seeking a Manager/Senior Manager, Biomarker & Biospecimen Operations to oversee biospecimen collection, tracking, shipment, reconciliation, vendor management, and biomarker logistics across clinical programs. You will partner with Translational Medicine, Clinical Ops, Data Management, and QA to ensure high-quality, compliant biospecimen operations throughout trials.

This role focuses on chain-of-custody, data reconciliation, lab oversight, and vendor governance to support