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1+ months

Cell Therapy Specialist

Kelly Services
Chicago, IL 60684
**Cell Therapy Specialist (6-month contract to hire)**


**Location:** Chicago, IL


Kelly is seeking a driven and experienced Cell Therapy Specialist, U.S. Hub Operations. Reporting to the Hub Supervisor, the successful candidate will initially support startup activities in support of hub qualification and operational readiness. Responsibilities include, preparing materials for site qualifications, supporting and/or executing end-to-end training runs, environment performance qualification, aseptic media simulations, tumor tissue processing, media preparation, right first-time initiatives, and supporting the Manufacturing Technical Services team in creating manufacturing documents Standard Operating Procedures (SOPs), batch records, etc.


As a Tumor Hub CTS, you may be required to execute tasks on behalf of central, global functions such as facilities and engineering, quality, supply chain and MSAT.


The role is not required to be on a shift pattern and will require significant flexibility to operate on afternoons or late nights for just-in-time tumor tissue processing.


**Key responsibilities**


+ Projects

+ Be capable of executing hub-prioritized tasks at the hub on behalf of global functions.

+ Operational Readiness

+ Routinely monitor, clean, and prepare manufacturing equipment through execution of equipment wipe-downs and cleaning as needed to ensure hub operational readiness.

+ Routine Operations

+ Execute tumor digest steps using closed systems and aseptic processing, from tissue receipt through material packout and shipping as an operator or verifier.

+ Provide runner support for clinical operations personnel conducting tumor digest processing steps inside the cleanrooms, acting as the bridge between storage and preparation areas. Perform the verification role for key process steps.

+ Complete training and qualification requirements, execute tasks according to written instructions.

+ Communicate effectively and escalate issues on the floor to MFG management.

+ Assist with execution of local facility qualification and maintenance activity while working with global business partners (F&E/Quality/Validation) to ensure that service providers and landlord processes are adhered to.

+ Execute tasks as directed by the Hub supervisor for equipment and systems used at the Hub.

+ Conduct environmental monitoring and sampling for facility environmental monitoring programs.

+ Capable of gowning and working within a cleanroom; perform aseptic processing within a BSC while wearing PPE.

+ Receive, store, control and maintain media and material inventories in alignment with supply chain business and quality requirements. Identify temperature-controlled unit excursions, respond and communicate impacts to the Hub supervisor and support corrective actions.

+ Be capable of travel to company facilities within local and the global network (travel up to 15%).

+ Preparing and packaging of materials, samples for cold-chain shipment for pick-up by courier services.

+ Assist MSAT and Clinical operations teams conduct root cause investigations by providing observations; Own non-product impact investigations (e.g. equipment or system alarms, calibration out of tolerances, etc.)

+ Support internal and external audits


**Qualifications**


+ BS degree in Life Sciences, Engineering, Applied Physics, or a related field with 3+ years of GMP manufacturing or Quality related experience

+ Knowledge of cGMP's and GDPs knowledge in a manufacturing facility is a must, including Cell Therapy experience preferred

+ Previous cleanroom operation; aseptic processing and cell culture processing experience

+ Experience in operating manual and automated process equipment.

+ Excellent communications and writing skills with direct experience supporting GMP operations.

+ Adapting and thriving in a rapidly changing and fast-moving environment, ability to work off-shift and extra hours as required

+ Skill in Microsoft Word, Excel, and minor data analysis (cell growth during manufacturing process)

+ Be capable of independently lifting up to 50lbs


**Skills**


+ Be capable of identifying events and communicating to the Hub supervisor as needed.

+ Understand the requirements of a regulated pharmaceutical environment.

+ Excellent verbal and written communication, task sequence planning and organization skills. Be able to recognize consequences and impacts on operations from changes in schedules associated with resources such as material, equipment, etc.

+ Demonstrated knowledge of manufacturing and quality systems used in manufacturing of pharmaceutical and biotechnology products, aseptic processing.

+ Ability to evaluate risk to patient, think critically and demonstrate troubleshooting and problem-solving skills.

+ Ability to function independently and adapt to a changing environment.

+ Well-developed computer skills, function easily within a Microsoft Office and SharePoint environment.

+ Self-motivated and willing to accept temporary responsibilities outside of initial job description; adapting and thriving in a rapidly changing and fast-moving environment, ability to work off-shift and extra hours as required.


**You should know:** Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.


**Why Kelly** **** **?**


Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.


**About Kelly** ****


At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)

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Posted: 2022-03-28 Expires: 2022-05-30

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Cell Therapy Specialist

Kelly Services
Chicago, IL 60684

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