Manager, Sample Management Operations (Biotech)

TL;DR

Manager, Sample Management Operations (Biotech): Overseeing end-to-end sample management across clinical pipeline studies with an accent on workflow standardization and vendor coordination. Focus on optimizing chain of custody, reducing operational risks, and ensuring inspection readiness.

Location: Hybrid in Somerset, New Jersey, United States

Salary: $127,313 - $167,099 USD

Company

A global biotechnology company dedicated to developing advanced cell therapies for treating and curing life-threatening diseases.

What you will do

• Manage the operating model and standardize workflows for sample management across sites, CROs, and specialty labs.
• Establish visibility into critical handoffs, chain of custody, and reconciliation activities.
• Monitor operational trends to proactively identify and mitigate risks associated with lost or delayed samples.
• Lead sample tracking and oversight capabilities through vendor management.
• Collaborate with cross-functional stakeholders including Data Management, QA, and ITQA to reduce operational burdens at sites.
• Support and prepare for inspections, audits, and quality reviews related to sample operations.

Requirements

• Bachelor’s degree in a scientific, healthcare, or related discipline.
• 7+ years of experience in pharmaceutical, biotech, or CRO clinical research.
• Proven experience in clinical operations with exposure to sample management or lab operations.
• Working knowledge of GCP, FDA, and ICH Guidelines.
• Must be based in or able to work from Somerset, NJ.
• Ability to travel up to 10%.

Nice to have

• Advanced degree.
• Experience with central labs, specialty labs, or sample tracking solutions.
• Experience in oncology, cell therapy, or early-phase clinical development.

Culture & Benefits

• Comprehensive medical, dental, and vision insurance, including flexible spending and health savings accounts.
• 401(k) retirement plan with a company match that vests fully on day one.
• Generous leave policy: 8 weeks of paid parental leave and comprehensive PTO (vacation, sick, and personal time).
• Additional perks: Legal assistance, life and AD&D insurance, and supplemental plans (pet, critical illness).
• Commitment to a supportive culture through well-being initiatives and peer-to-peer recognition.