Bioprocessing Assistant - Cook Group

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 Bioprocessing Assistants 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.

• Performs all work with strict adherence to cGMPs, the company Quality System, and safety standards.
• Ability to obtain and maintain required internal company qualifications, including but not limited to: gowning qualification, visual inspector qualification
• Maintains the integrity of the manufacturing suite through strict adherence to proper cleanroom behavior and aseptic practices.
• 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.
• 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.
• Operators are required to wear a PAPR or half face respirator in addition to other PPE such as glasses/goggles while performing room sanitizations.
• Performs critical process control measurements on daily basis: manual and automated culture monitoring, cell count and viability assay using flow cytometer.
• 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.
• 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 department
• Provides real-time support to associates performing aseptic interventions: trash removal, collection and documentation of product flasks, verbal and physical verification of critical procedures.
• Assists in the creation, editing, and implementation of quality system records (Investigations, SOPs, WIs, BTRs) to optimize the manufacturing process.
• Ability to troubleshoot basic issues and clearly communicate unusual issues to the attention of the production supervisors.
• Assists in training new personnel.

• 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 analyze situations or data
• Able to prioritize and operate proactively

On-Site

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

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

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 successfully complete Production Associate training program

Critical thinking and organizational skills
Excellent oral and written communication skills
Must work and interact effectively and professionally with others
Excellent problem-solving skills and ability to work in collaborative and independent work situations and environments with minimal supervision

Physical Requirements:

• 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 standing, walking, stooping, kneeling, crouching, climbing steps and ladders, 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 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.
• Must be capable of performing PPE gowning procedures, aseptically for up to 5.5 hours at a minimum of one time per year.
• Must be able to extend arms outright for extended periods of time, periodically at intervals for up to 3 hours at a time.
• 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 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.