Senior Manager, Clinical Supply Chain

Job not on LinkedIn

🔥 14 hours ago

🍂 Massachusetts – Remote

🍂 Massachusetts – Remote

💵 $156.5k - $183.4k / year

⏰ Full Time

🟠 Senior

🔗 Supply Chain

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

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TScan Therapeutics

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 2018

🏥 Healthcare

🧬 Biotechnology

💊 Pharmaceuticals

Healthcare • Biotechnology • Pharmaceuticals

TScan Therapeutics is a clinical-stage biopharmaceutical company dedicated to changing lives by discovering new cancer targets and developing safe and effective T cell therapies for patients. Their innovative approach involves leveraging insights from patients who have successfully fought cancer to inform the development of new treatments. TScan is focused on unleashing the untapped potential of the human immune system to create impactful T cell therapies for various malignancies.

📋 Description

• Lead clinical supply chain activities, including label text generation, labeling and packaging operations, global distribution, inventory management, and investigational product reconciliation • Develop and maintain supply plans aligned with clinical enrollment projections, dosing requirements, regulatory timelines, and clinical study milestones • Provide operational oversight of contract organizations involved in packaging, labeling, and distribution • Author, review, and approve clinical label text, multi-country clinical label designs, packaging batch records, pharmacy manuals, and clinical supply sections of study-related documents • Manage investigational product aspects of IRT systems, including specifications, product availability and release status, shipment authorizations, and study blind integrity • Develop supply risk mitigation strategies and manage risks related to study timelines, supply availability, expiry, inventory levels, and protocol updates • Partner with Quality and Clinical stakeholders on SOPs, batch records, lot-release documentation, change controls, deviations, investigations, and CAPAs • Manage sourcing of ancillary IV infusion supplies for clinical sites • Ensure adherence to FDA, EMA, ICH, GCP, and GMP regulations

🎯 Requirements

• Bachelor’s degree in supply chain, scientific or related field required • 8+ years of Clinical Supply Chain management in the pharmaceutical or biotechnology industry • Experience planning and executing clinical supply strategies for complex, global clinical studies • Experience managing labeling, packaging, distribution, inventory management, product reconciliation, and forecasting • Experience supporting injectable programs requiring cold-chain storage and distribution • Experience managing import and export activities for global clinical studies, focused on North America and Europe • Strong operational and project management skills • Experience managing multiple programs, vendors, and deliverables simultaneously • Proficiency working with 3rd party IRT systems, including IP-related specification development • Experience overseeing Unblinded Clinical Supply activities, including site pharmacy inquiries and temperature excursions • Excellent verbal and written communication and interpersonal skills • Ability to exercise independent judgment with minimal supervision • Ability to work in a US-based remote position • Minimum quarterly travel to Entrada Therapeutics Headquarters in Boston, MA

🏖️ Benefits

• Comprehensive health, dental and vision coverage • Life and disability insurance • 401(k) match • Paid, gender-inclusive parental leave • Holistic support for health and well-being • Education reimbursement • Discretionary time off • Commuting benefits aligned to working model • Remote work arrangement

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