Senior Manager, Clinical Supply Chain jobs in United States
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Janux Therapeutics · 2 months ago

Senior Manager, Clinical Supply Chain

Janux Therapeutics is focused on advancing clinical programs, and they are seeking a Senior Manager of Supply Chain to oversee the clinical supply chain operations. This role involves collaboration with various functions to ensure timely drug supply and effective management of clinical trial materials.

BiotechnologyHealth DiagnosticsPharmaceuticalTherapeutics

Responsibilities

Prepare, maintain, and periodically re-evaluate demand forecasts and supply strategies to ensure uninterrupted IMP supply to clinical sites while minimizing product waste throughout the clinical trial
Contribute to and review Interactive Response Technologies (IRT) specifications; manage IRT systems in alignment with the overall supply strategy
Collaborate with cross-functional teams to create and approve labeling designs in compliance with regulatory requirements
Manage packaging activities at the Clinical Packaging Organization (CPO) and coordinate with QA for release
Contribute to the preparation and review of clinical trial pharmacy manuals and packaging batch records
Oversee distribution and inventory of clinical trial material across depots and sites
Manage drug return, destruction process, and accountability at the depots
Coordinate material shipments from CDMO to storage facilities and CPOs
Review and approve third-party vendor invoices, ensuring accuracy and compliance with contractual terms
Partner with QA on quality events, investigations, deviations/CAPA, batch record review and drug disposition
Manage expiry date extensions, documentation, and related distribution activities
Participate in forecast meetings with Clinical Operations. Prepare presentation materials and communicate inventory updates and operational strategies
Identify and lead process improvement initiatives to enhance efficiency and compliance
Perform other responsibilities as assigned

Qualification

Clinical supply chain managementCGMPGCP regulationsInventory managementBiologics manufacturing processesLogistic systemsShippingRisk mitigation strategiesEffective communication

Required

Bachelor's degree in a scientific or pharmaceutical discipline
6+ years of biotechnology/pharmaceutical industry experience with direct experience in clinical supply chain management
Inventory management and vendor oversight experience in all phases of drug development for biologics with global clinical supply distribution is required
Strong knowledge of cGMP, GCP regulations, and Annex 13 and VI
Solid understanding of clinical research protocol requirements and experience developing IRT specifications
Experience with logistic systems and shipping required
Effective communication and direction
Ability to identify project risks and rapidly develop and implement risk mitigation strategies in a fast-paced environment with changing priorities

Preferred

Familiarity with biologics manufacturing processes is highly desirable

Benefits

401K
Medical insurance
Dental insurance
Vision insurance
Supplemental disability insurance plans
Flexible schedule
Life insurance
Flexible vacation
Sick time
Incentive stock option plan
Relocation assistance
Annual targeted bonus %

Company

Janux Therapeutics

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Janux Therapeutics develops immunotherapies that generates immune responses to prevent tumors and not affecting a patient’s healthy tissue.

Funding

Current Stage
Public Company
Total Funding
$898.94M
Key Investors
RA Capital ManagementAvalon Ventures
2024-12-03Post Ipo Equity· $350M
2024-02-29Post Ipo Equity· $296.5M
2023-07-17Post Ipo Equity· $60M

Leadership Team

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David Campbell
President, CEO & Director (Founder)
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Byron Robinson
Chief Strategy Officer
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Company data provided by crunchbase