Bioprocessing Assistant

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. Weu2019re 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 youu2019re curious, motivated by helping others, and driven by integrity, we invite you to apply. The Bioprocessing Assistant job is to ensure the uninterrupted manufacturing and release of cellular products which meet company Quality System standards, standard operating procedures, and regulatory requirements by facilitating daily production tasks. Responsibilities u2022 Performs all work with strict adherence to cGMPs, the company Quality System, and safety standards.u2022 Ability to obtain and maintain required internal company qualifications, including but not limited to: gowning qualification, visual inspector qualificationu2022 Maintains the integrity of the manufacturing suite through strict adherence to proper cleanroom behavior and aseptic practices.u2022 Manages essential materials involved in the processing of product and upkeep of the manufacturing suite continuously: inventory management, material orders from warehouse, material movement through multiple ISO classified rooms.u2022 Maintains cleanroom manufacturing suite by performing procedures including but not limited to: routine room and equipment sanitizations, documenting and initiation of routine/emergency maintenance requests, removal of biohazard trash.u2022 Operators are required to wear a PAPR or half face respirator in addition to other PPE such as glasses/goggles while performing room sanitizations.u2022 Performs critical process control measurements on daily basis: manual and automated culture monitoring, cell count and viability assay using flow cytometer.u2022 Performs cross-contamination mitigation procedures to include but not limited to: processing area changeover, process setup and clearance, biological safety cabinet sanitizations, label printing and verification.u2022 Supports the manufacturing process and trial requirements by performing or assisting with the following: quarantine and storage of Phase I and II cellular products and placebos, submission and transfer of samples from manufacturing to Quality Control departmentu2022 Provides real-time support to associates performing aseptic interventions: trash removal, collection and documentation of product flasks, verbal and physical verification of critical procedures.u2022 Assists in the creation, editing, and implementation of quality system records (Investigations, SOPs, WIs, BTRs) to optimize the manufacturing process.u2022 Ability to troubleshoot basic issues and clearly communicate unusual issues to the attention of the production supervisors.u2022 Assists in training new personnel. u2022 Exemplifies Cook MyoSite Core Valuesu2022 Maintain regular and punctual attendanceu2022 Must maintain company quality and safety standardsu2022 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.u2022 Ability to work in collaborative and independent work situations and environments with minimal supervisionu2022 Maintain composure and competence under stressful situations; demonstrate flexibility and adaptabilityu2022 Must work and interact effectively and professionally with and for others throughout various levels of the global organization to achieve company goalsu2022 Trainabilityu2022 Must have effective verbal, written and interpersonal skillsu2022 Able to analyze situations or datau2022 Able to prioritize and operate proactively Qualifications Associates degree in any Life Science or Engineering Field or 4 years direct, relevant experience in laboratory work to provide a comparable background 1-3 years' experience in laboratory role including gowning procedures and standard operating procedures Proficient knowledge of Microsoft Office software, and other general office equipment. Full Time On Site Physical Requirements: u2022 Ability to conduct and hear ordinary conversation and telephone communication.u2022 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.u2022 Ability to work under specific time constraints.u2022 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.u2022 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.u2022 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.u2022 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.u2022 Physically capable of standing, walking, stooping, kneeling, crouching, climbing steps and ladders, reaching, twisting and bending on occasion with or without reasonable accommodations.u2022 Must be able to lift/push/pull up to 50 pounds on an occasional basis with or without reasonable accommodations.u2022 Must be capable of performing PPE gowning procedures on a frequent basis to enter BioSafety Level II including safety glasses, lab coat, gloves, specialized clothing including laboratory scrubs (pants and shirt) hood, facial mask and appropriate shoes required on a regular basis.u2022 Must be capable of performing PPE gowning procedures, aseptically for up to 5.5 hours at a minimum of one time per year.u2022 Must be able to extend arms outright for extended periods of time, periodically at intervals for up to 3 hours at a time.u2022 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. Employee that does not interact with Healthcare ProfessionalsCompliance 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 donu2019t just accept difference u2014 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. Requisition ID2025-17581 Posting Date2 months ago(11/5/2025 3:24 PM) Job Location(s)Pittsburgh PA United States Job LocationsUS-PA-Pittsburgh TravelLess than 10% Position TypeFull Time CompanyCook Myosite Inc. CategoryProduction/MFG/Operations

Created: 2026-01-21