Cook MyoSite, Inc. 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 Planning Coordinator plans and coordinates the entire supply chain process and materials associated with Autologous Cell and Laboratory Research manufacturing. The Planning Coordinator ensures all planning activities are compliant with all company standards, operating procedures, Quality System regulations and requirements.
• Responsible for end-to-end supply chain planning operations associated with the manufacture of all GMP, Clinical, and Laboratory Research products.
• Responsible for applicable ERP master data settings for raw materials
• Responsible for planning raw material and prepared material inventories
• Create and report on applicable KPI’s or Metrics relevant to the position
• Point person for technical and compliance issues and liaisons with internal groups (QA, QC, Regulatory etc.) to facilitate issue resolution with a sense of urgency
• Manage GMP product Cycle Time with all internal stakeholders through consistent communication and issue resolution
• Lead or participate on daily operations meeting to ensure effective up to date communication and status for all GMP products and related issues
• Coordinates scheduling of products and prepared material batches with the manufacturing team
• Laboratory Research Planning and Product Management for raw materials and finished goods inventories
• Coordinates cross-functional communication and troubleshooting to ensure zero downtime for manufacturing
• Must be able to understand and apply lean principles to applicable processes
• Assists in writing, tracking, and managing Investigations, Corrective Actions, and Change Controls to facilitate product Cycle Time
• Respond to departmental and organizational planning activities with both sense of urgency and thorough analysis
• Manage relationships with and negotiate with vendors
• Undergraduate degree in Life Sciences, Business Administration, Operations, or 6 years direct, relevant experience in a supply chain planning or biotech operations role to provide a comparable background
• Professional experience working in a regulated industry and environment (Pharmaceutical, Biotech, Medical Device) in a supply chain planning or operations role
• Certifications: APICS, CPSM or CPIM certification a plus.
• Experience and competency with ERP systems
• In-depth understanding of cGMP, 21 CFR Part 11, and related regulations associated with Bio/Pharmaceutical manufacturing and best practices (e.g. ISPE GAMP) a plus
• Up to date with changes in technology and the business implications/applications of new technologies
• Office Setting: General office, warehouse and laboratory setting.
• Ability to conduct and hear ordinary conversation and telephone communication.
• Must be able to work extended hours beyond normal work schedule to include, but not limited to, evenings, weekends, extended work hours and/or extra work hours, sometimes on short notice as required.
• Ability to work under specific time constraints.
• Must be able to sit at desk, in meetings and/or work on a computer for long or extended periods of time.
• Visual and manual acuity for working with computers and equipment.