ZipRecruiter

Log In

1

Fda Cber Jobs in Silver Spring, MD (NOW HIRING)

All JobsFda Cber JobsFda Cber Jobs in Silver Spring, MD

Fda Cber information

See Silver Spring, MD salary details

$14

$53

$72

How much do fda cber jobs pay per hour?

As of Jul 31, 2026, the average hourly pay for fda cber in Silver Spring, MD is $53.95, according to ZipRecruiter salary data. Most workers in this role earn between $46.73 and $65.62 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.
What are popular job titles related to Fda Cber jobs in Silver Spring, MD? For Fda Cber jobs in Silver Spring, MD, the most frequently searched job titles are:
What job categories do people searching Fda Cber jobs in Silver Spring, MD look for? The top searched job categories for Fda Cber jobs in Silver Spring, MD are:
What cities near Silver Spring, MD are hiring for Fda Cber jobs? Cities near Silver Spring, MD with the most Fda Cber job openings:
Fda Cber jobs near you
Infographic showing various Fda Cber job openings in Silver Spring, MD as of July 2026, with employment types broken down into 2% As Needed, 16% Full Time, 67% Part Time, 2% Temporary, 11% Contract, and 2% Nights. Highlights an 81% Physical, 4% Hybrid, and 15% Remote job distribution, with an average salary of $112,224 per year, or $54 per hour.

Senior Specialist, Cell Therapy Trade Compliance (FTZ)

AstraZeneca

Gaithersburg, MD • On-site

Full-time

Medical, Dental, Vision, Retirement, PTO

Re-posted 13 days ago

AstraZeneca rating

8.4

Company rating: 8.4 out of 10

Based on 45 frontline employees who took The Breakroom Quiz

20th of 86 rated pharmaceutical

Job description

At AstraZeneca Cell Therapy, we are building the capabilities required to deliver complex, personalized therapies through a highly coordinated, patient-centered, and globally scalable supply chain. In cell therapy, every movement matters. The reliable and compliant flow of patient materials, critical manufacturing inputs, intermediates, and finished product is essential to protecting product integrity, supporting manufacturing continuity, and helping therapies reach patients on time.
The Senior Specialist, Cell Therapy Trade Compliance - Free Trade Zone Operations plays a critical role in that mission by leading Free Trade Zone (FTZ) operations at AstraZeneca's cell therapy manufacturing sites. This role helps ensure materials can move compliantly, predictably, and with full traceability through import/export and FTZ processes, while maintaining strong inventory control, audit readiness, and alignment to vein-to-vein timelines and manufacturing schedules. This is an opportunity to work at the intersection of trade compliance, cell therapy logistics, and patient-centered operations, helping build the cross-border capabilities needed to support future growth and the next generation of personalized medicines.
You will be responsible for the day-to-day operation of FTZ activities that support the compliant movement and control of materials across the cell therapy network. You will work closely with Manufacturing, Supply Chain, Logistics, Quality, brokers, and external partners to ensure high execution quality, strong documentation practices, and reliable support for time-critical operations.
Key Responsibilities
  • Lead FTZ operations and compliance: Manage FTZ execution in line with 19 CFR Part 146 (Foreign Trade Zones), internal procedures, and site requirements, including admissions, status elections, zone-to-zone transfers, removals, exports, weekly entries, and annual reconciliation activities.
  • Support compliant material controls: Help ensure FTZ-compliant storage and movement of patient-specific materials and critical raw materialswith strong attention to traceability, segregation, documentation accuracy, and operational control.
  • Maintain Inventory, controland audit-ready records: Operate and maintain accurate FTZ inventory records within approved systems, support cycle counts and reconciliations, and ensure documentation is complete and compliance, and manage access controls.
  • Coordinate import execution and broker activities: Review and support import documentation and entry activities, including alignment to HTS classification, valuation, origin, and FDA/CBER import requirements, while partnering with customs brokers and internal stakeholders to resolve issues quickly and compliantly.
  • Support outbound FTZ shipment execution: Coordinate outbound movements from the FTZ for intermediates and finished product, ensuring documentation, customs processes, and shipment controls are completed accurately and on time.
  • Partner cross-functionally to support patient and manufacturing timelines: Work closely with Manufacturing, Quality, Supply Chainto align FTZ activities with batch release and patient schedules.
  • Track performance and identify improvement opportunities: Monitor KPIs such as inventory accuracy, admission cycle time, entry accuracy, customs holds, and exception trends, and support root cause analysis and corrective actions that improve reliability, compliance, and operational efficiency.
  • Maintain procedures and support training: Help develop and maintain SOPs, work instructions, and role-based training materials for FTZ and import/export processes, while supporting knowledge sharing and consistent execution across the network.

Essential Qualifications
  • Bachelor's degree in Supply Chain, International Business, Logistics, Life Sciences, or a related field.
  • 5+ Years experience in customs brokerage, import/export operations, trade compliance, or global logistics, including hands-on experience with FTZ or bonded operations.
  • Strong working knowledge of FTZ operations, customs documentation, broker coordination, and import/export execution.
  • Familiarity with 19 CFR Part 146, HTS classification, customs valuation, and FDA/CBER import requirements.
  • Experience working in a regulated environment; experience in biopharma, advanced therapies, or temperature-controlled logistics is preferred.
  • Experience maintaining accurate records, supporting audits or inspections, and working within controlled systems and documented procedures.
  • Attention to detail, ability to manage multiple priorities, and comfort working in a fast-paced and highly controlled operational environment.
  • Strong written and verbal communication skills, with the ability to work effectively across internal teams and external partners.
  • Proficiency in Excel and familiarity with inventory systems, broker portals, or logistics/trade systems.

Desirable Skills / Experience
  • Experience supporting cell therapy, biologics, advanced therapies, or other highly controlled healthcare logistics environments.
  • Familiarity with GDP, GMP, GxP, and documentation practices relevant to regulated logistics and trade operations.
  • Experience supporting temperature-controlled, cryogenic, or time-sensitive material movements.
  • Experience with operational reporting, KPI tracking, and continuous improvement activities.

#CellTherapy
The annual base pay for this position ranges from $89K to $134K. Our positions offer eligibility for various incentives-an opportunity to receive short-term incentive bonuses, equity-based awards for salaried roles and commissions for sales roles. Benefits offered include qualified retirement programs, paid time off (i.e., vacation, holiday, and leaves), as well as health, dental, and vision coverage in accordance with the terms of the applicable plans.
Date Posted
24-Jul-2026
Closing Date
02-Aug-2026
Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.

What AstraZeneca employees say

Pay

Benefits

Hours and flexibility

Workplace

Get the full story on Breakroom

Apply