Associate Principal Scientist, Biologics Process Validation

Gaithersburg, Maryland

This job has expired.

At AstraZeneca, we turn ideas into life changing medicines. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. We're focused on the potential of science to address the unmet needs of patients around the world. We commit to those areas where we think we can really change the course of medicine and bring big new ideas to life.

Our Gaithersburg, Maryland facility creates life-changing medicines for people around the world. This campus employs more than 3,500 experts in our field and is only a short drive from Washington, DC. The Gaithersburg site offers a variety of amenities to help boost productivity 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. This is where you'll find newly-designed, activity-based work spaces to suit a variety of working styles while increasing collaboration between teams. Come and thrive in our vibrant, energizing, connected and encouraging culture and make a difference to patients. Hear from our Senior Leaders about why they know AstraZeneca is a great place to work.

The Biologics Process Validation Associate Principal Scientist's core responsibilities will focus on the preparation and distribution of good practices throughout the enterprise. The role will also ensure that new uplifting agile process validation methodology is aligned or enabled within the Global Validation policies. This role will require collaboration and influence across Global Technical Operations (GTO) functional teams, Biologics Process Development, Global and Site Validation Process Champions as well as subject matter experts across the enterprise to produce new guidelines, procedures and training packages for process validation methodology. As a subject matter expert in process validation, the role offers extensive opportunities for technical consultation in to CMC teams as well as internal and external project teams to define deliverables and strategies for process validation.

What you'll do:

  • Participate/Lead and contribute to Process Validation community of practice for process validation and the Biologics Validation Working Group meetings and hold working sessions to build new ways of working in process validation in alignment with current initiatives for agile process validation.
  • Research state-of-the art methodology and information from ISPE, PDA and other organizations/publications and regulatory trends within the industry to evaluate applicability to AstraZeneca.
  • Author/review validation best practice guidelines, procedures and standards. Provide expert knowledge to teams on global regulatory requirements for process validation.
  • Evaluate new technology and approaches to qualification and process validation including data analytics.
  • Provide consultation to technology transfer teams and provide subject matter expertise in process validation
  • Work with Development, the Global MS&T network, GTO functional leads, the PV community of practices , quality and regulatory to ensure that validation instructions (good practices, procedure, guidelines) follow the validation lifecycle and are simple and effective.

Essential for the role:
  • Bachelor's Degree in an engineering or scientific subject area.
  • Minimum of 10 years' experience in process validation.
  • Minimum of 5 years' experience working in Life Sciences or Engineering.
  • Significant experience working in a cGMP production setting.
  • Global leadership working across functional teams within the process validation discipline.
  • Must be a driver of change and maintain a continuous improvement mindset.

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 entrepreneurial - 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 cutting edge methods and bringing unexpected teams together. Interested? Come and join our journey.

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 a great fit, please share this posting with them.

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