Head of Apheresis
Austin, TX · On-site
Own the licensure pathway end to end: blood establishment registration (FDA Form 2830), the BLA (Form FDA 356h) to CBER / OBRR, and the strategy for licensed vs. unlicensed product and interstate ...
Head of Apheresis
Austin, TX · On-site
Own the licensure pathway end to end: blood establishment registration (FDA Form 2830), the BLA (Form FDA 356h) to CBER / OBRR, and the strategy for licensed vs. unlicensed product and interstate ...
Super Office Director, Office of Therapeutic Products (OTP)
Silver Spring, MD · On-site +1
$259K - $373K/yr
Ensures that office functions and program activities are aligned to the overall strategy and priorities of CBER and FDA. * Facilitates Super Office staff coordination between multiple, smaller ...
Super Office Director, Office of Therapeutic Products (OTP)
Silver Spring, MD · On-site +1
$259K - $373K/yr
Ensures that office functions and program activities are aligned to the overall strategy and priorities of CBER and FDA. * Facilitates Super Office staff coordination between multiple, smaller ...
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.
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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.
Research Director, Duke Margolis Institute for Health Policy Hybrid (Washington DC or Durham NC)
Durham, NC · On-site
Direct experience in relevant FDA CDER and CBER regulatory issues. * Proven ability to write business documents and manage project execution, including budget development and financial management.
Research Director, Duke Margolis Institute for Health Policy Hybrid (Washington DC or Durham NC)
Durham, NC · On-site
Direct experience in relevant FDA CDER and CBER regulatory issues. * Proven ability to write business documents and manage project execution, including budget development and financial management.
Direct experience in relevant FDA CDER and CBER regulatory issues. * Proven ability to write business documents and manage project execution, including budget development and financial management.
Direct experience in relevant FDA CDER and CBER regulatory issues. * Proven ability to write business documents and manage project execution, including budget development and financial management.
Research Director, Duke Margolis Institute for Health Policy Hybrid (Washington DC or Durham NC)
Durham, NC · On-site
Direct experience in relevant FDA CDER and CBER regulatory issues. * Proven ability to write business documents and manage project execution, including budget development and financial management.
Research Director, Duke Margolis Institute for Health Policy Hybrid (Washington DC or Durham NC)
Durham, NC · On-site
Direct experience in relevant FDA CDER and CBER regulatory issues. * Proven ability to write business documents and manage project execution, including budget development and financial management.
... by FDA CDER or CBER, such as drugs, biologics, or advanced therapies * Experience with Bayesian, frequentist, and empirical methods * Experience supporting and advising government leadership or ...
... by FDA CDER or CBER, such as drugs, biologics, or advanced therapies * Experience with Bayesian, frequentist, and empirical methods * Experience supporting and advising government leadership or ...
Quality Engineer 3
$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
$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 ...
Vial Filling Process Manager (2nd Shift)
$78K - $112K/yr
... cGMPs, CBER, WHO, EP , and other applicable regulatory bodies. Key responsibilities include ... Prior experience in an FDA-regulated industry is required * Working knowledge of cGMPs is required
Vial Filling Process Manager (2nd Shift)
$78K - $112K/yr
... cGMPs, CBER, WHO, EP , and other applicable regulatory bodies. Key responsibilities include ... Prior experience in an FDA-regulated industry is required * Working knowledge of cGMPs is required
Vial Filling Process Manager (2nd Shift)
$78K - $112K/yr
... cGMPs, CBER, WHO, EP , and other applicable regulatory bodies. Key responsibilities include ... Prior experience in an FDA-regulated industry is required * Working knowledge of cGMPs is required
Vial Filling Process Manager (2nd Shift)
$78K - $112K/yr
... cGMPs, CBER, WHO, EP , and other applicable regulatory bodies. Key responsibilities include ... Prior experience in an FDA-regulated industry is required * Working knowledge of cGMPs is required
Experience working with CBER (FDA) regulated licensed biologics. The Key Working Relationships Internal Partners: Quality Control Lab, Quality Engineers, Quality Assurance, Regulatory Affairs ...
Experience working with CBER (FDA) regulated licensed biologics. The Key Working Relationships Internal Partners: Quality Control Lab, Quality Engineers, Quality Assurance, Regulatory Affairs ...
Vial Filling Process Manager (2nd Shift)
$78K - $112K/yr
... cGMPs, CBER, WHO, EP , and other applicable regulatory bodies. Key responsibilities include ... Prior experience in an FDA-regulated industry is required * Working knowledge of cGMPs is required
Vial Filling Process Manager (2nd Shift)
$78K - $112K/yr
... cGMPs, CBER, WHO, EP , and other applicable regulatory bodies. Key responsibilities include ... Prior experience in an FDA-regulated industry is required * Working knowledge of cGMPs is required
Vial Filling Process Manager (2nd Shift)
$78K - $112K/yr
... cGMPs, CBER, WHO, EP , and other applicable regulatory bodies. Key responsibilities include ... Prior experience in an FDA-regulated industry is required * Working knowledge of cGMPs is required
Vial Filling Process Manager (2nd Shift)
$78K - $112K/yr
... cGMPs, CBER, WHO, EP , and other applicable regulatory bodies. Key responsibilities include ... Prior experience in an FDA-regulated industry is required * Working knowledge of cGMPs is required
Vial Filling Process Manager (2nd Shift)
$78K - $112K/yr
... cGMPs, CBER, WHO, EP , and other applicable regulatory bodies. Key responsibilities include ... Prior experience in an FDA-regulated industry is required * Working knowledge of cGMPs is required
Vial Filling Process Manager (2nd Shift)
$78K - $112K/yr
... cGMPs, CBER, WHO, EP , and other applicable regulatory bodies. Key responsibilities include ... Prior experience in an FDA-regulated industry is required * Working knowledge of cGMPs is required
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 ...
Vial Filling Process Manager (2nd Shift)
$78K - $112K/yr
... cGMPs, CBER, WHO, EP , and other applicable regulatory bodies. Key responsibilities include ... Prior experience in an FDA-regulated industry is required * Working knowledge of cGMPs is required
Vial Filling Process Manager (2nd Shift)
$78K - $112K/yr
... cGMPs, CBER, WHO, EP , and other applicable regulatory bodies. Key responsibilities include ... Prior experience in an FDA-regulated industry is required * Working knowledge of cGMPs is required
Experience working with CBER (FDA) regulated licensed biologics. The Key Working Relationships Internal Partners: Quality Control Lab, Quality Engineers, Quality Assurance, Regulatory Affairs ...
Experience working with CBER (FDA) regulated licensed biologics. The Key Working Relationships Internal Partners: Quality Control Lab, Quality Engineers, Quality Assurance, Regulatory Affairs ...
Experience working with CBER (FDA) regulated licensed biologics. The Key Working Relationships Internal Partners: Quality Control Lab, Quality Engineers, Quality Assurance, Regulatory Affairs ...
Experience working with CBER (FDA) regulated licensed biologics. The Key Working Relationships Internal Partners: Quality Control Lab, Quality Engineers, Quality Assurance, Regulatory Affairs ...
Experience working with CBER (FDA) regulated licensed biologics. The Key Working Relationships Internal Partners: Quality Control Lab, Quality Engineers, Quality Assurance, Regulatory Affairs ...
Experience working with CBER (FDA) regulated licensed biologics. The Key Working Relationships Internal Partners: Quality Control Lab, Quality Engineers, Quality Assurance, Regulatory Affairs ...
... by FDA CDER or CBER, such as drugs, biologics, or advanced therapies * Experience with Bayesian, frequentist, and empirical methods * Experience supporting and advising government leadership or ...
... by FDA CDER or CBER, such as drugs, biologics, or advanced therapies * Experience with Bayesian, frequentist, and empirical methods * Experience supporting and advising government leadership or ...
Fda Cber information
See salary details
$13.70 - $18.86
2% of jobs
$18.86 - $24.02
1% of jobs
$24.02 - $29.17
2% of jobs
$29.17 - $34.33
3% of jobs
$34.33 - $39.49
5% of jobs
$39.49 - $44.65
11% of jobs
$44.89 is the 25th percentile. Wages below this are outliers.
$44.65 - $49.80
17% of jobs
The median wage is $52.11 / hr.
$49.80 - $54.96
20% of jobs
$54.96 - $60.12
11% of jobs
$61.32 is the 75th percentile. Wages above this are outliers.
$60.12 - $65.28
15% of jobs
$65.28 - $70.43
14% of jobs
$13
$52
$70
How much do fda cber jobs pay per hour?
As of Aug 6, 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 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.
How to become an FDA CBER investigator?
To become an FDA CBER investigator, candidates typically need a bachelor's degree in a relevant scientific field such as biology, chemistry, or biomedical sciences, along with experience in regulatory science or biomedical research. Federal employment also requires meeting specific qualification standards and passing a background check, with some roles requiring advanced degrees or specialized training in regulatory processes. Familiarity with FDA regulations, good manufacturing practices, and inspection procedures is essential for this role.
What is an FDA CBER?
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.
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Join Parachute rating
6.4
Based on 9 frontline employees who took The Breakroom Quiz
Job description
oin Parachute operates a national, software-enabled biologics platform with 55 plasma and blood collection centers across 20 states, serving over 500k donors. That footprint is the foundation for a clinical apheresis programs serving the hospital transfusion market.
We are focusing on apheresis platelets to start.
We're hiring our first Head of Apheresis to design, license, and launch our apheresis platelet program across the network - and to build the manufacturing-quality-regulatory engine that every transfusion product after it will run on.
You will own the product from blank page to first licensed unit: product and process design, the SOP library, the quality system, equipment selection and validation, the bacterial risk control strategy, blood establishment computer software (BECS) validation, donor eligibility, ISBT 128 labeling, and the Biologics License Application itself.
Year 1 (License & Launch)
- Define the apheresis platelet product strategy: collection platform (Trima Accel / Amicus), single/double/triple yield targets, leukoreduction, and the bacterial risk control strategy - pathogen reduction (e.g., INTERCEPT), large-volume delayed sampling, or secondary rapid testing - and the 5- vs. 7-day dating decision that flows from it.
- Author the SOP library, quality manual, and validation master plan to 21 CFR Part 606 (cGMP for blood) and AABB Quality System Essentials - document control, training and competency, CAPA, deviation management, and biological product deviation reporting (606.171 / eBPDR).
- Own the licensure pathway end to end: blood establishment registration (FDA Form 2830), the BLA (Form FDA 356h) to CBER / OBRR, and the strategy for licensed vs. unlicensed product and interstate distribution. Defend the application and answer to FDA.
- Lead equipment, reagent, and process validation (IQ/OQ/PQ) across the collection and component-manufacturing chain.
- Partner with the software team to validate our software for platelet component management - donor deferral interlocks, test-result release logic, ISBT 128 labeling, and Circular of Information compliance.
- Stand up donor eligibility and qualification per 21 CFR Part 630, the infectious-disease testing plan (NAT/serology) and lab interfaces, and the release/quarantine framework.
- Drive to a successful Pre-License Inspection (FDA Team Biologics) and First Licensed Unit Released within 9-12 months of start.
- Hire and onboard a Quality/Regulatory lead and an Operations/Manufacturing PM.
Year 2+ (Scale)
- Roll apheresis platelets across the center network; own per-unit economics, yield, and the metric that makes or breaks a platelet program - outdate rate.
- Expand the product menu: whole blood (including low-titer O whole blood for trauma), leukoreduced red cells, and, where the case is there, cold-stored platelets, irradiated and CMV-negative inventory.
- File and clear the supplements that growth requires - prior approval supplements (PAS) for new products and new sites - and keep the license current.
- Build hospital and transfusion-service distribution: supply agreements, cold-chain logistics, and the hemovigilance feedback loop.
- Own the FDA inspection lifecycle, the AABB accreditation cycle, and CLIA/CAP for any in-house testing; lead lookback, recall, and market-withdrawal processes.
- Build the operating model and SOP architecture that lets a new center or a new product launch in weeks, not quarters.
- 8+ years in blood-component or biologics manufacturing, quality, or regulatory at a blood center, blood bank, or licensed biologics establishment.
- Led or supported the launch or licensure of at least one blood component or biologic product line through the FDA - author the quality system, own the inspection, get the product released.
- Working command of 21 CFR Parts 606, 610, 630, and 640, the BLA/licensure framework under 600/601, ISBT 128, and AABB Standards.
- Hands-on apheresis platelet operations - Trima Accel and/or Amicus - and direct experience with at least one bacterial risk control strategy (pathogen reduction, LVDS, or rapid testing).
- Has authored an SOP library and built/run a QMS to 606 + AABB QSEs, including CAPA, deviation, validation, and biological product deviation reporting.-
- Pathogen reduction implementation (e.g., Cerus INTERCEPT) from validation through routine release.
- Donor-center collection operations experience, not only the transfusion-service side of the house.
- Start-up or scale-up operating experience: building the system, not inheriting it.
- Cold-stored platelet variance, 7-day dating implementation, or HLA/HPA-matched platelet programs.
What You Are Not
- A hospital transfusion-service / blood-bank manager who has only issued products, never manufactured and licensed them. Different skill set.
- regulatory affairs writer without operations scars. Reg affairs files the submission; this role runs the floor that the submission describes.
- A consultant who advised on a BLA but never owned a deviation, an outdate rate, or a 483.
- collections operator without the quality and regulatory depth to actually get a product licensed.
How We Work
Lean and execution-oriented. We hire operators, not headcount-buyers.
Direct communication and short feedback loops. If something is broken, you fix it, then write the SOP - not the other way around.
Regulatory rigor with start-up speed. We will not cut corners on cGMP or donor safety, and we will not let process theater slow us down.
You will have meaningful budget authority and the autonomy to make tradeoffs. You will also be accountable for outcomes - licensed units released, sites live, outdate rate - not activity.
