Product Quality Senior Specialist

Gaithersburg, Maryland

This job has expired.

At AstraZeneca, we work together across global boundaries to make an impact and find answers to challenges. We do this with the upmost integrity even in the most difficult situations because we are committed to doing the right thing. We continuously forge partnerships that help pursue world-class medicines in new ways, combining our people's outstanding skills with those of people from all over the globe.

Our Gaithersburg, Maryland facility builds life-changing medicines for people around the world. The modern, vibrant scientific campus employs more than 3000 guides in our field, and it is only a short drive from Washington, DC. It is filled with groundbreaking technology. Our labs spaces were built to facilitate collaboration, interaction and cross functional science. We believe employees benefit from being challenged and encouraged at work. We offer everything from bean bag rooms for creative brain storming, game rooms and Zen garden to treadmill stations and regular campus happy hours. The Gaithersburg site offer a variety of amenities to help boost efficiency and help keep our employees happy and healthy. This includes a fitness center, employee healthcare clinic, electric vehicle charging stations, dry cleaning, full-service cafeteria and copy center.

Join AstraZeneca and help us deliver life-changing medicines! Be among our employees who continue to make us an innovation-driven company that stands firmly among the leaders in BioPharmaceuticals.

What you'll do: As the Product Quality Senior Specialist you will be responsible for ensuring the quality of licensed and clinical products manufactured here in Gaithersburg, Maryland.


  • Represent Quality at CMC Teams and GST (Global Supply Team) as the "Voice of Quality", as liaison for the entire Quality function
  • Support several early stage and late stage biologic pipeline products
  • Represent Quality on cross-functional project teams
  • Responsible for all Quality related deliverables to the CMC Team
  • Maintain Quality understanding from cell banking through post-release events (e.g., stability, product complaints)
  • Review regulatory filings
  • Provide consistent Quality approach and GMP guidance
  • Responsible for Quality product-focused activities associated with technology transfers
  • Critically review product and process data for trends
  • Advise on technical issues from the Quality perspective
  • Participate in investigations of major deviations and drive team toward identification of true root cause

Essential Education/Experience:

  • 5 - 8 years experience and B.S. in Biology, Biochemistry, Chemistry, Engineering or related field
  • > 3 years experience with M.S.
  • > 1 year experience with Ph.D.
  • CMC experience for biologics
  • Understanding of biologic manufacturing and process development
  • Understanding of early phase, late phase and commercial lifecycle process development activities
  • Strong executable knowledge of protein chemistry, chemistry and biologic systems

Desirable Experience:
  • Working knowledge of Quality processes and systems
  • Regulatory filing experience
Why AstraZeneca?

At AstraZeneca when we see an opportunity for change, we seize it and make it happen, because any opportunity no matter how small, can be the start of something big. Delivering life-changing medicines is about being bold - finding those moments and recognizing their potential. Join us on our journey of building a new kind of organization to reset expectations of what a bio-pharmaceutical company can be. This means we're opening new ways to work, groundbreaking innovative methods and bringing unexpected teams together. Interested? Come and join our journey.

Are you already imagining yourself joining our team? Good, because we can't wait to hear from you.

Next Steps - Apply today!

To be considered for this exciting opportunity, please complete the full application on our website at your earliest convenience - it is the only way that our Recruiter and Hiring Manager can know that you feel well qualified for this opportunity. If you know someone who would be an outstanding fit, please share this posting with them.

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.

AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.

This job has expired.

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