Supply Chain Planning Specialist

Overview
Cook MyoSite, Inc., part of the Cook Group, Inc. family of companies, is on a mission to make regenerative medicine a part of everyday medicine. We’re investigating our core technology, autologous muscle-derived cells, for the potential treatment of several muscle-related disorders. We at Cook MyoSite have the potential to make a difference in the lives of countless people around the world, and we also have the potential to make a difference in yours. Joining our team is an opportunity to ignite your passion, grow your potential, and define your purpose. If you’re curious, motivated by helping others, and driven by integrity, we invite you to apply.
The Supply Chain Specialist at Cook MyoSite will plan, coordinate, and execute end-to-end supply chain activities supporting Iltamiocel and Custom Cell Solutions manufacturing, ensuring timely material availability while maintaining full compliance with company policies, standard operating procedures, and applicable Quality System and regulatory requirements.
Responsibilities

• Responsible for end-to-end supply chain planning operations associated with the manufacture of all GMP, Clinical, and Laboratory Research products.
• Plan, monitor , and maintain raw material, prepared material, and fi nished goods inventories to meet manufacturing demand while minimizing risk of shortages or excess inventory
• Create, release, and manage purchase requisitions , sales orders, and material transactions, including activities performed outside of the ERP system when required
• Manages tracking of human biological specimens (Tissue, cells, and derivative products) collected for manufacturing investigational and commercial products.
• Serve as primary point of contact for internal and external stakeholders, facilitating clear, timely and effective communication to ensure alignment
• Initiates prepared material batches and coordinates requirements with internal groups Assists in maintaining Patient Work Orders for the tracking of patient products through the manufacturing life cycle
• Serves as Therapy Champion for the Supply Chain Orchestration system (OCELLOS)
• Initiate and support Quality System documentation, including product and material batch record requests, biopsy receiving, and the writing, tracking, and management of Investigations, Corrective Actions, and Change Controls to support product cycle time
• Coordinate with manufacturing, quality, warehouse, logistics , and procurement teams to align supply plans and operational p riorities
• Identify supply risks, shortages , and capacity constraints and proactively implement mitigation plans to prevent disruptions

Qualifications

• Undergraduate degree in Supply Chain Management, Business Analytics, or related field . Undergraduate degree in Life Science with 1 + years relevant supply chain or operations experience; or equivalent relevant supply chain or operations experience
• Proficient knowledge of Microsoft Office software, and other general office equipment.
• Basic understanding of cGMP, 21 CFR Part 11, and related regulations associated with Bio/Pharmaceutical product manufacturing
• Experience working in a regulated industry and environment (Pharmaceutical, Biotech, Medical Device) preferred
• Certifications: APICS, CPSM or CPIM certification a plus .
• Ability to multi-task
• Willingness to learn and adapt in a fast pace environment
• Must possess excellent organizational skills and the ability follow complex processes, procedures and systems
• Possess exceptional work ethic
• Demonstrate critical thinking and ability to execute goals set by the mentor, or Department Manager
• Proficiency in MS Office and other general office equipment
• Must maintain a high level of professionalism, business acumen
• Must have effective verbal, written and interpersonal skills
• Maintain composure and competence under stressful situations; flexibility and adaptability
• Ability to work in collaborative and independent work situations and environments

Physical Requirements

• General office setting
• Must be able to sit at desk, in meetings and/or work on a computer for long or extended periods of time
• Ability to conduct and hear ordinary conversation and telephone communication
• Visual and manual acuity for working with computers and equipment
• Must be able to work a normal work schedule of 40 hours per week
• Ability to work under specific time constraints.