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.
Front Line Leadership is primarily tasked with departmental decisions and output on activities related to quality, operations, and the business. They are accountable to Senior Leadership and Directors for their department or functional area and are the technical experts.
Front Line Leadership functions include managing departmental resources appropriately, assessing performance, providing feedback, and identifying gaps. Front Line Leadership also must be skilled communicators, able to convey clear expectations, listen for feedback, and provide updates in a timely manner.
The Laboratory Research Services Operations Manager will lead, develop and coordinate activities of department staff relating to manufacturing Laboratory Research Services (LRS) products including activities of production, quality control testing, supply chain management, development, material inventory, and laboratory maintenance.
Ensure non-GMP and GMP operations do not overlap and cause compliance issues
Oversee inventory levels to ensure timely and proper preparation of media, bulk solutions, filling and labeling of vials under sterile conditions
Manage staff responsible for the following and backfill as necessary for:
• Dissociation of human tissue to establish cell cultures
• Routine aseptic cell culture maintenance (media changes and passages)
• Cell culture harvesting, formulation, and filling for releasable products
• Operating routine laboratory equipment, including but not limited to; Incubators, centrifuges, balances, BSHs, -20°C/-80°C freezers, liquid nitrogen storage units
• Performing established quality control assays including cell count and viability assays using a flow cytometer, sterility, mycoplasma, endotoxin, potency, and other associated in-process and release tests.
• Maintaining the quarantine, storage, and inventory counts of manufactured master cell banks and final products
• Cleaning of laboratories
• Sanitization of laboratory equipment in accordance with set procedures
• Inventory management, and ordering, to maintain an adequate supply of resources for manufacturing of products
• Collecting and properly dispose of biohazard waste
• Performing established processing area preparation and change over procedures for product interventions, routine sanitization of BSHs, and product lot clearance
Perform preliminary review of required information in manufacturing batch records and associated forms prior to sending information to Quality Assurance for final review
Initiate and author quality system records (i.e. investigations)
Collaborate with Quality Assurance to resolve issues and continuously improve processes
Perform troubleshooting, bringing potential investigations to the attention of senior management
• Undergraduate degree in any Life Sciences or Engineering field or 6 years direct, relevant experience in a laboratory / manufacturing environment to provide a comparable background
• Minimum of 4 years' experience in a biologics /medical device / biopharmaceutical manufacturing environment.
• Aseptic cell culture experience
• Full Time On Site
• Laboratory Setting (Non-Production: General office, warehouse and laboratory setting with potential (limited) exposure to hazardous chemicals and/or harsh disinfectants while in BioSafety Level II.
• 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 on a regular basis and periodically for up to 3 hours at time.
• Ability to spend majority of day standing in laboratory setting or sitting in biological safety hood setting with potential (limited) exposure to hazardous chemicals and/or harsh disinfectants while in BioSafety Level II or other labs.
• Must be able to maintain manual acuity for working with computers and equipment.
• Must be able to extend arms outright for extended periods of time, periodically at intervals for up to 3 hours at a time.
• Physically capable of reaching, twisting and bending on occasion with or without reasonable accommodations.
• Must be able to lift/push/pull up to 50 pounds on an occasional basis with or without reasonable accommodations.
• Must be able to maintain focus, aseptic qualifications and performance standards of position for extended periods of time without rest periods; periodically at intervals for up to 5.5 hours at a time.