Bioprocessing Associate I

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

Responsibilities

• Performs daily work with strict adherence to cGMPs, the company Quality System, and safety standards • Able to obtain and maintain required internal company qualifications, including but not limited to; gowning qualification, aseptic qualification • Follows proper cleanroom behavior and aseptic practices while working inside the manufacturing suite and cleanroom environments • Performs preparation of media, bulk solutions, filling and labeling of vials under sterile conditions • Performs dissociation of human tissue to establish cell cultures • Performs routine cell culture maintenance (media changes and passages) • Performs terminal cell culture harvesting, formulation, and filling for releasable products • Performs collection and submission of product generated and environmental monitoring samples • Documents, and reviews, required information in Production batch records and associated forms in a timely fashion • Initiates and authors quality system records (i.e. investigations) • Operates routine laboratory equipment, including but not limited to; Incubators, centrifuges, balances, BSHs, -20°C/-80°C freezers, liquid nitrogen storage units • Performs troubleshooting, bringing potential investigations to the attention of the Supervisor • Performs established cell count and viability assays using a flow cytometer • Performs routine daily culture monitoring of products; both manually, and using an automated system • Performs the quarantine and storage of manufactured products • Assists with routine sanitizations of laboratories and the manufacturing suite with required use of half-faced respirator and/or PAPR along with additional PPE • Assists with routine sanitization of manufacturing laboratory equipment in accordance with set procedures • Assists with inventory management, and ordering, to maintain an adequate supply of resources for manufacturing of products • Collects and properly disposes of biohazard waste • Performs established processing area preparation and change over procedures for product interventions, routine sanitization of BSHs, and product lot clearance • Assists department in improving/optimizing manufacturing processes

Qualifications

Undergraduate degree in any Life Sciences or Engineering field or 6 years direct, relevant experience in a laboratory environment to provide a comparable background

Proficient knowledge of Microsoft Office software, and other general office equipment.

 

Full Time On-Site

 

• 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 verba, written interpersonal skills

 

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 cor