Biomanufacturing Technician

Cleveland Clinic

3d•Onsite

About The Position

At Cleveland Clinic Health System, we believe in a better future for healthcare. And each of us is responsible for honoring our commitment to excellence, pushing the boundaries and transforming the patient experience, every day. We all have the power to help, heal and change lives — beginning with our own. That’s the power of the Cleveland Clinic Health System team, and The Power of Every One. 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.

Requirements

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, cGMP 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

Nice To Haves

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

Responsibilities

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.