Laboratory Research Associate I

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 Laboratory Research Associate I is tasked with manufacturing cellular products which meet company Quality System standards, standard operating procedures, and regulatory requirements. 

• Perform daily work with strict adherence to cGMPs, the company Quality System, and safety standards
• Perform preparation of media, bulk solutions, filling and labeling of vials under sterile conditions
• Perform dissociation of human tissue to establish cell cultures
• Perform routine cell culture maintenance (media changes and passages)
• Perform terminal cell culture harvesting, formulation, and filling for releasable products
• Perform collection and submission of product generated and environmental monitoring samples
• Perform and/or assist in the manufacture of non-GMP Research Use Only (RUO) products and services
• Document and review required information in Production batch records and associated forms in a timely fashion
• Initiate and author quality system records (i.e. investigations)
• Operate routine laboratory equipment, including but not limited to; Incubators, centrifuges, balances, BSHs, -20°C/-80°C freezers, liquid nitrogen storage units
• Perform troubleshooting, bringing potential investigations to the attention of the Manager
• Perform established cell count and viability assays using a flow cytometer
• Perform routine daily culture monitoring of products; both manually, and using an automated system
• Perform the quarantine and storage of manufactured products
• Assist with routine cleaning of laboratories.
• Assist with routine sanitization of laboratory equipment in accordance with set procedures
• Assist with inventory management, and ordering, to maintain an adequate supply of resources for manufacturing of products
• Collect and properly dispose of biohazard waste
• Perform established processing area preparation and change over procedures for product interventions, routine sanitization of BSHs, and product lot clearance
• Assist department in improving/optimizing manufacturing processes

• Exemplifies Cook MyoSite Core Values
• Maintain regular and punctual attendance
• Must maintain company quality and safety standards
• This position requires an ongoing commitment to upgrading knowledge, job skills and abilities in addition to competency related to all duties and responsibilities listed above.
• Ability to work in collaborative and independent work situations and environments with minimal supervision
• Maintain composure and competence under stressful situations; demonstrate flexibility and adaptability
• Must work and interact effectively and professionally with and for others throughout various levels of the global organization to achieve company goals
• Trainability
• Must have effective verbal, written and interpersonal skills
• Able to prioritize and operate proactively

• 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 6 years' experience in a biologics /medical device / biopharmaceutical manufacturing environment preferred

• Knowledge and application of industry standards and guidelines/regulations related to the manufacturing of sterile injectable drug and biologic products (21 CFR 210 and 211) and cGMPs preferred

• Proficient knowledge of Microsoft Office software, and other general office equipment
• Ability to learn and support new systems and applications, and the ability to provide technical training to end users
• Basic understanding of cGMP, 21 CFR Part 11, and related regulations associated with Bio/Pharmaceutical product manufacturing

Physical Requirements:

Laboratory Setting (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.
• A minimum of 20/20 vision with or without correction with both eyes on the Pocket Vision Screener from 14 inches. A minimum of 20/20 vision with or without correction in both eyes on Graham Field Eye test chart from 10 feet. Must be able to identify colors on the Ishihara Charts of Color Deficiency.
• 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.

Training Compliance: Employee that does not interact with Healthcare Professionals
Compliance with all policies of the company including without limitation the Cook Employee Manual, Cook Code of Conduct, Quality System Manual, Cook Electronic Information Policy and HIPAA regulations.

At Cook MyoSite, we don’t just accept difference — we celebrate it, we support it, and we thrive on it for the benefit of our employees, our products, and our community. Cook MyoSite is proud to be an equal opportunity workplace.
This job description features the essential and critical functions of the position described and is not an exhaustive list of tasks and/or responsibilities. This may be subject to change at any time due to reasonable accommodation or other reasons.