Cleveland Clinic
Biomanufacturing Technician - Jos Melenhorst Lab
Cleveland Clinic, Cleveland, Ohio, us, 44101
Overview
Join to apply for the Biomanufacturing Technician - Jos Melenhorst Lab role at Cleveland Clinic. The Melenhorst Lab focuses on translational T cell and tumor immunology research, with an emphasis on chimeric antigen receptor (CAR) T-cell therapies. The lab studies CAR T-cell interactions with tumor cells and the tumor microenvironment, as well as patient responses, to identify mechanisms of response and resistance and improve therapeutic efficacy in hematologic malignancies.
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. You will apply GMP and biotherapeutics expertise 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 PCR analysis.
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.
Improve 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.
Qualifications Minimum qualifications
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
Preferred qualifications
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
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.
Pay Range Minimum Annual Salary: $52,270.00
Maximum Annual Salary: $79,727.50
The pay range displayed on this job posting reflects the anticipated range for new hires. A successful candidate’s actual compensation will be determined after taking factors into consideration such as the candidate’s work history, experience, skill set and education. The pay range displayed does not include any applicable pay practices (e.g., shift differentials, overtime, etc.). The pay range does not include the value of Cleveland Clinic’s benefits package (e.g., healthcare, dental and vision benefits, retirement savings account contributions, etc.).
Job Details
Seniority level: Entry level
Employment type: Full-time
Job function: Science
Industries: Hospitals and Health Care
Our caregivers continue to create the best outcomes for our patients across each of our facilities.
#J-18808-Ljbffr
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. You will apply GMP and biotherapeutics expertise 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 PCR analysis.
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.
Improve 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.
Qualifications Minimum qualifications
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
Preferred qualifications
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
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.
Pay Range Minimum Annual Salary: $52,270.00
Maximum Annual Salary: $79,727.50
The pay range displayed on this job posting reflects the anticipated range for new hires. A successful candidate’s actual compensation will be determined after taking factors into consideration such as the candidate’s work history, experience, skill set and education. The pay range displayed does not include any applicable pay practices (e.g., shift differentials, overtime, etc.). The pay range does not include the value of Cleveland Clinic’s benefits package (e.g., healthcare, dental and vision benefits, retirement savings account contributions, etc.).
Job Details
Seniority level: Entry level
Employment type: Full-time
Job function: Science
Industries: Hospitals and Health Care
Our caregivers continue to create the best outcomes for our patients across each of our facilities.
#J-18808-Ljbffr