Advisor, Bio Sample Operations – DMPK

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🔥 0 minutes ago

🍂 Massachusetts – Remote

🍂 Massachusetts – Remote

💵 $153k - $268.4k / year

⏰ Full Time

🟠 Senior

🔴 Lead

⚙️ Operations

👻 Ghost score 0%

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Eli Lilly and Company

WebsiteLinkedInAll Job Openings

10,000+ employees

💊 Pharmaceuticals

🏥 Healthcare

🧬 Biotechnology

💰 $6.5M Post-IPO Debt - Eli Lilly on 2024-02

Pharmaceuticals • Healthcare • Biotechnology

Eli Lilly and Company is a multinational pharmaceutical company that researches, develops, manufactures, and markets prescription medicines across multiple therapeutic areas including diabetes, oncology, immunology, neuroscience, and pain. Headquartered in Indianapolis, Indiana, Lilly is known for its extensive R&D, clinical development, and global commercialization of biologic and small-molecule drugs. The company focuses on drug discovery, clinical trials, regulatory approvals, and large-scale pharmaceutical manufacturing and distribution.

📋 Description

• Lead bio sample operations across clinical studies from start-up through database lock, closeout and final sample disposition • Translate protocol and laboratory requirements into study-specific bio sample strategies, timelines, workflows, manuals, collection materials and operational plans • Oversee the end-to-end bio sample lifecycle, including collection, processing, labeling, shipment, receipt, storage, analysis, reconciliation, retention and disposition • Coordinate cross-functional teams and external partners to deliver bio sample activities on time, within budget and to required quality standards • Manage central and specialty laboratories, biorepositories, couriers, CROs and other vendors, including contracts, deliverables, performance, KPIs and SLAs • Maintain sample traceability, chain of custody, inventory accuracy and alignment across clinical, laboratory and sample-management systems • Identify, resolve and escalate operational and quality issues, including shipment problems, missing samples, discrepancies, deviations, CAPAs and audit or inspection findings • Ensure compliance with protocols, GCP regulations, internal SOPs, quality standards and regulatory requirements while improving processes through standardized tools, governance, metrics and lessons learned • Partner with Clinical Operations, Bioanalytical Sciences, Quality, Regulatory and external vendors in a cross-functional global environment

🎯 Requirements

• Bachelor's degree in life sciences, biotechnology, pharmacy, healthcare, clinical research or related discipline • 8+ years of relevant experience in pharmaceutical, biotechnology, CRO or clinical research environments • Experience in clinical trial operations, biospecimen management, laboratory or biomarker operations and clinical bio sample lifecycle management • Proven project management skills and ability to balance multiple complex priorities in a matrixed organization • Experience working cross-functionally and managing central and specialty laboratory vendors and other international partners • Strong knowledge of GCP principles, clinical research quality standards, global trials, and multi-country sample logistics • Experience with LIMS, bio sample or clinical trial management systems, sample tracking, reconciliation, and integration of laboratory and clinical data • Strong communication, organization, stakeholder management, and problem-solving skills • Ability to travel approximately 10%-20%, including visits to CROs and external partners as needed

🏖️ Benefits

• Company bonus depending in part on company and individual performance • Company-sponsored 401(k) • Pension • Vacation benefits • Medical, dental, vision and prescription drug benefits • Flexible benefits, including healthcare and/or dependent day care flexible spending accounts • Life insurance and death benefits • Certain time off and leave of absence benefits • Well-being benefits, including employee assistance program, fitness benefits, and employee clubs and activities • Employee resource groups and support networks