Supply Chain Planning Specialist

Cook Group•Pittsburgh, PA

2d•Onsite

About The Position

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. They are investigating their core technology, autologous muscle-derived cells, for the potential treatment of several muscle-related disorders. Joining their team is an opportunity to ignite passion, grow potential, and define purpose for curious, motivated, and integrity-driven individuals. 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.

Requirements

Undergraduate degree in Supply Chain Management, Business Analytics, or related field, or an 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.
Ability to multi-task.
Willingness to learn and adapt in a fast-paced environment.
Excellent organizational skills and the ability to follow complex processes, procedures, and systems.
Exceptional work ethic.
Critical thinking and ability to execute goals set by the mentor or Department Manager.
High level of professionalism and business acumen.
Effective verbal, written, and interpersonal skills.
Ability to maintain composure and competence under stressful situations; flexibility and adaptability.
Ability to work in collaborative and independent work situations and environments.

Nice To Haves

Experience working in a regulated industry and environment (Pharmaceutical, Biotech, Medical Device) preferred
APICS, CPSM or CPIM certification a plus.

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 finished 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 priorities
Identify supply risks, shortages, and capacity constraints and proactively implement mitigation plans to prevent disruptions