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Fda Cber Jobs (NOW HIRING)

Lead Medical Technologist

Brighton, MA · On-site

$81K - $110K/yr

May be required to enter exceptions and/or deviations to FDA through Centers for Biologics Evaluation and Research (CBER). May be required to enter errors or problems using SEMC rL Online Solutions.

Quality Engineer 3

San Diego, CA · On-site

$76K - $98K/yr

Working knowledge of applicable FDA and ISO regulations and expectations, including CDRH, CBER, 21 CFR Part 820, 21 CFR Part 11, ISO 13485 and ISO 14971. * Cleanroom manufacturing experience ...

Quality Engineer 3

San Diego, CA · On-site

$76K - $98K/yr

Working knowledge of applicable FDA and ISO regulations and expectations, including CDRH, CBER, 21 CFR Part 820, 21 CFR Part 11, ISO 13485 and ISO 14971. * Cleanroom manufacturing experience ...

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Fda Cber information

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How much do fda cber jobs pay per hour?

As of Jul 14, 2026, the average hourly pay for fda cber in the United States is $52.19, according to ZipRecruiter salary data. Most workers in this role earn between $45.19 and $63.46 per hour, depending on experience, location, and employer.

What are the key skills and qualifications needed to thrive in the Fda Cber position, and why are they important?

To thrive at FDA CBER (Center for Biologics Evaluation and Research), you need expertise in biological sciences, regulatory affairs, and data analysis, often supported by an advanced degree in a relevant scientific field. Familiarity with regulatory databases, clinical trial management systems, and guidance documents such as CFR Title 21 is crucial. Strong analytical, communication, and teamwork skills help you effectively evaluate product safety and efficacy while coordinating with diverse stakeholders. These abilities ensure that biologic products are rigorously reviewed for safety, quality, and compliance with federal regulations.

What is the scope of CBER?

The FDA Center for Biologics Evaluation and Research (CBER) oversees the regulation of biological products, including vaccines, blood products, and gene therapies, ensuring their safety, efficacy, and quality. CBER's scope includes reviewing clinical data, issuing approvals, and monitoring post-market safety for biologics. Professionals working in CBER need knowledge of regulatory policies, clinical trial processes, and biological sciences.

What are the typical daily responsibilities of someone working at FDA CBER?

Professionals at FDA CBER are usually involved in reviewing scientific data, assessing regulatory submissions for biologics, writing evaluation reports, and participating in team meetings to discuss product review findings. They commonly collaborate with scientists, physicians, and policy experts to ensure biologic products meet safety and efficacy standards. Day-to-day tasks may also include responding to inquiries from industry sponsors, developing policy guidance, and staying abreast of advances in biologic product development. This dynamic environment allows for constant learning and impact on public health through regulatory science.

Who is the new head of the FDA CBER?

As of October 2023, the director of the FDA Center for Biologics Evaluation and Research (CBER) is Dr. Peter Marks. He oversees the regulation of biologics, including vaccines, blood products, and gene therapies, and has held this position since 2016. Leadership roles at CBER can change, so checking the FDA website provides the most current information.

What is an FDA CBER job?

An FDA CBER job refers to a position within the Center for Biologics Evaluation and Research (CBER) at the U.S. Food and Drug Administration (FDA). CBER regulates biological products, including vaccines, blood products, and gene therapies, to ensure their safety and effectiveness. Employees in CBER roles may work in regulatory affairs, scientific research, policy development, or compliance oversight. These positions typically require expertise in biology, medicine, or regulatory science.

What is the CBER in the FDA?

The Center for Biologics Evaluation and Research (CBER) is a division of the FDA responsible for regulating biological products such as vaccines, blood products, and gene therapies. Jobs at CBER often require knowledge of regulatory science, compliance standards, and relevant scientific or medical expertise. Employees ensure the safety, efficacy, and quality of biologics before they reach the market.

Is it hard to get hired by the FDA?

Getting hired as an FDA CBER employee can be competitive due to strict qualification requirements, including relevant education, experience, and security clearances. The hiring process often involves multiple interviews, background checks, and assessments of technical knowledge related to regulatory and scientific standards.
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Lead Medical Technologist

Lead Medical Technologist

Staffingine LLC

Brighton, MA • On-site

$81K - $110K/yr

Full-time

Re-posted yesterday


Job description

Job Title: Lead Medical Technologist 
Job Location: Brighton, MA
Job Type:  Full Time

Job Description:  

  • Reviews and evaluates daily and periodic Quality Control testing and procedures. 

  • Ensures performance of periodic instrument maintenance and departmental quality control procedures.  Coordinates CAP survey performance and reporting. 

  • Assists with creation of validation plans as may be required for equipment or procedures, and ensures completion of validation package for final review. 

  • Performs Meditech validation exercises as may be required with system upgrades or site specific changes. Ensures department is prepared for planned Meditech downtime. 

  • Monitors transfusion activity at contracted transfusion service client sites for regulatory compliance; may be required to make periodic site visits. 

  • Acts as liaison with Nursing Education to evaluate and/or update mandatory training material. May be asked to assist with creating lessons. Assists with ensuring Blood Bank policies are appropriately posted to SEMC MCN Policy Manager. 

  • Ensures blood product inventory levels are adequate for transfusion support and works to reduce product wastage. 

  • Tracks data for quality improvement monitors as defined by Blood Bank Supervisor. 

  • Assist in the collection and preparation of Continuous Quality Improvement (CQI) projects. 

  •  Offers ideas for future CQI projects that will benefit the department and hospital. 

  • Actively participates in the Hospital Performance Improvement Program. May act as Blood Bank representative at interdepartmental/interdisciplinary meetings or for collaborative projects. 

  • Observes functions of the section, and makes suggestions on ways to better streamline 

  • Oversees the administration of proficiency testing and ensures participation of all staff. 

  • Assists in the reviewing of policies and procedures, advising on and creating  Standard Operating Procedures (SOPs). 
     

Retrieves, compiles, prepares and processes reports and logs (statistical, management, patient, client) as appropriate: 

  • Monitors Turnaround time for identified tests 

  • Reviews daily specimen review log for accuracy. 

  • Collects data for analysis as may be required by contractual obligations or for internal reporting, such as Transfusion Committee. 

  • Ensures that all billable testing performed in the Blood Bank or by contracted vendors is appropriately recorded in Meditech, including the movement of requisitions to appropriate patient accounts. 

  • Coordinates all training for section employees in all required procedures ensuring implementation of standards for performance and directing 

follow through on performance improvement measures: 

  • Assumes responsibility for training of all new staff in all necessary areas of the section. 

  • Monitors and maintains competency of all staff  on an annual basis. Monitors staff compliance with mandatory  training assigned by SEMC to ensure completion. 

  • Makes recommendations regarding individual performance of staff. 

  • Conducts periodic drills for staff on emergency measures such as disaster drills or MTP drills or other. 

  • Contributes to ongoing compliance with all applicable regulatory agencies for the section (including but not limited to AABB, JCAHO, CAP, OSHA, DPH, NCCLS, and CLIA). Reviews applicable AABB Standards and CAP Checklists for departmental compliance and assists with any functions as required to achieve compliance. 

  • Assist Blood Bank supervisor in laboratory quality assurance and quality control, compliant with FDA, AABB, CAP regulations/requirements and” best practices” as required . 

  • Assists as needed with provision of data or demonstration of processes as may be required during an inspection. May be required to tabulate and report monthly transfusion data to National Health Service Network (NHSN). May be required to enter exceptions and/or deviations to FDA through Centers for Biologics Evaluation and Research (CBER). May be required to enter errors or problems using SEMC rL Online Solutions. 

  • Keeps abreast of current technical/professional information. 
     

REQUIRED EDUCATION AND EXPERIENCE:  
 

  • Associate’s degree in medical technology or related science and 3-5 years’ full time experience as Clinical Laboratory Technologist, or equivalent combination of education and experience.  
     

PREFERRED EDUCATION AND EXPERIENCE : 
 

  • Bachelor's degree in Medical Technology or a related science, attainment of degree within 6 months of start date.  

  • 6 years in an accredited blood center or transfusion service.  
     

CERTIFICATIONS, LICENSES, REGISTRATIONS PREFERRED: 

  • ASCP certification or equivalent preferred.  
     

KNOWLEDGE, SKILLS & ABILITIES (KSAs): 

  • Knowledge of complex laboratory procedures.  

  • Possesses communication skills sufficient to clearly, completely and accurately verbally relay laboratory data.  

  • Knowledge of known risk and biohazards in the lab environment.  
     

Must-Haves: 

  • Associate’s degree in medical technology or related science 

  • 3 years full-time experience as Clinical Laboratory Technologist 

  • ASCP certification or equivalent preferred