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Job Title

Biomanufacturing Technician

Location

Cleveland

Facility

Cleveland Clinic Main Campus:

Department

LRI Center for Immunotherapy and Immuno Oncology-Research Innov and Educ

Job Code

T97561

Shift

Days

Schedule

8:00am-4:30pm

Job Summary

Job Details

Join Cleveland Clinic Research and become a part of one of the most respected healthcare organizations in the world. Cleveland Clinic values research, innovation and education by conducting leading-edge research that improves the lives of patients today and in the future. Here, you will work alongside passionate and dedicated caregivers, receive endless support and appreciation and build a rewarding career.

As a Biomanufacturing Technician within the Cell Therapy and Immuno-Engineering Program (CTIP) at Cleveland Clinic Research, you will join an interdisciplinary team dedicated to translating innovative laboratory discoveries into novel immunotherapies for patients with hematologic and solid cancers. In this role, you will apply your expertise in Good Manufacturing Practice (GMP) and biotherapeutics to support the production and release of investigational cell and gene therapies for phase I/II clinical trials. This position also collaborates with the adjacent Quality Control laboratory, which conducts compendial and developmental assays with a focus on flow cytometry and polymerase chain reaction (PCR) analysis.

A caregiver in this role works days from 8: 00 a.m. – 5:00 p.m. (flexible start/end times) with availability for occasional evenings or weekends as needed.

A caregiver who excels in this role will:

• Serve as a subject matter expert, using GMP and biotherapeutics expertise to contribute to the production and release of investigational cell and gene therapies to support phase I/II clinical trials.

• Focus on clinical manufacturing and laboratory testing, with additional support in process development activities.

• Provide daily, hands-on support for cGMP production and/or quality testing of cell and gene therapies.

• Maintain an operational cleanroom facility including routine maintenance of controlled environment, conduct environmental monitoring, cleanroom cleaning and instrument checks.

• Prepare, operate, monitor and troubleshoot equipment, i.e. automated cell processors, analytical instruments.

• Write, revise and update Standard Operating Procedures.

• Complete documentation per GMP and GDP standards including batch records, test records, tracking data and reporting trends.

• Generate, analyze and present quality and/or analytical data associated with the GMP facility.

• Assist in activities related to process development, assay development, manufacturing and quality.

• Improves manufacturing processes and workflows.

• Adhere to cGMP, FDA, FACT and Cleveland Clinic policies and guidelines.

• Develop in-depth expertise for all regularly performed activities and share knowledge within the team.

• Lead by example to create a strong culture of safety, quality and continuous improvement within the team.

• Complete assigned training and continuing education activities.

Minimum qualifications for the ideal future caregiver include:

• Associate’s degree in biotechnology, pharmaceutical sciences, or related field and four years of experience in research, clinical or industrial laboratory

• OR Bachelor’s degree in biomedical or pharmaceutical sciences, engineering, or related field and two years of experience in research, clinical or industrial laboratory

• Experience and/or knowledge in mammalian cell culture, aseptic technique, flow cytometry, immunology, c

GMP and writing SOPs:

• Familiarity with clinical documentation and regulatory filings

• Strong understanding of GMP regulations

• Analytical skills, problem solving and independent judgement to address diverse problems

Preferred qualifications for the ideal future caregiver include:

• Bachelor’s degree in biomedical or pharmaceutical sciences, engineering, or related field

• Clinical manufacturing experience

• Experience/knowledge with Good Manufacturing Practice (GMP) in the pharmaceutical industry or in food or cosmetics GMP

Our caregivers continue to create the best outcomes for our patients across each of our facilities. Click the link and see how we’re dedicated to providing what matters most to you: https://jobs.clevelandclinic.org/benefits-2/

Physical Requirements:

• Ability to perform work in a stationary position for extended periods

• Ability to operate a computer and other office equipment

• Ability to communicate and exchange accurate information

• Ability to distinguish color

• Manual dexterity to handle specimens and repair equipment

• Ability to lift and transport equipment or specimens weighing up to 20 pounds

• May be exposed to hazardous chemicals, bio-hazards, radioactive materials, etc.

Personal Protective Equipment:

• Follows standard precautions using personal protective equipment as required.

The policy of Cleveland Clinic Health System and its system hospitals (Cleveland Clinic Health System) is to provide equal opportunity to all of our caregivers and applicants for employment in our drug free environment. All offers of employment are followed by testing for controlled substances.

Cleveland Clinic Health System administers an influenza prevention program. You will be required to comply with this program, which will include obtaining an influenza vaccination on an annual basis or obtaining an approved exemption.

Decisions concerning employment, transfers and promotions are made upon the basis of the best qualified candidate without regard to color, race, religion, national origin, age, sex, sexual orientation, marital status, ancestry, status as a disabled or Vietnam era veteran or any other characteristic protected by law. Information provided on this application may be shared with any Cleveland Clinic Health System facility.

Please review the Equal Employment Opportunity poster.

Cleveland Clinic Health System is pleased to be an equal employment employer: Women / Minorities / Veterans / Individuals with Disabilities