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Process Lead

Lieu Frederick, Maryland, États-Unis Job ID R-121080 Date de publication 10/07/2021

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 exceptional skills with those of people from all over the globe.

Our Frederick Manufacturing Center (FMC) is one of 30 production facilities in 18 countries that builds life-changing medicines for people around the world. This biologics manufacturing facility makes a direct contribution to treating people with cancer, respiratory and autoimmune conditions across the globe. It’s challenging but highly rewarding work, involves more than 675 talented people throughout the manufacturing lifecycle and supporting office functions. We work hard to deliver life-changing medicines to patients, and we take time to have fun and celebrate our accomplishments. From catered site festivities to competitive events, community outreach activities, environmental and wellness showcases and team-building events, we take time to recognize our achievements.

We are dedicated to creating a culture of inclusion and collaboration. We are committed to continuous learning and offer ongoing skill building and training for our staff and encourage additional secondary schooling with tuition reimbursement of 100% up to $10,000 each year. The FMC is also an award-winning employer and has been recognized as a ‘Top 50’ Business in Frederick and awarded Frederick County’s ‘Best Place to Work’ distinction in 2015 and 2019. Come join our award-wining team and support the manufacture of life-changing medicines for patients across the world.

As a Process Lead in the Manufacturing group at Frederick, MD, you’ll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients’ lives.

8 hours days.

What you’ll do:

The Process Lead is the operational subject matter expert to represent the shift and/or functional area as needed for investigations, CAPAs, and receipt of tech transfer information.  The Lead will also be responsible for operation of upstream / downstream / central services processing equipment according to established SOPs and driving continuous improvement opportunities. 

Direct on floor support (50-70% time on shop floor)

  • Qualified in Lead Technician duties and on-floor coaching

  • On the floor manufacturing execution as needed by shift supervisor

  • Shift representative for shop floor investigations and CAPA execution

In-direct floor support (30-50% time for support)

  • Trend process performance and data trending to assess batch performance

  • Lead and engage in continuous improvement projects

  • Author, review and approve batch records and direct SOPs for manufacturing

  • Final review of completed manufacturing documentation per compliance standards and

  • established timelines

  • Logbook reviews, where applicable

  • Assess training competency of and provide training to shift personnel

  • First line of defense for process and equipment troubleshooting on the shift

  • Identify and execute standardized work and process improvements

  • Demonstrated expertise in hands-on manufacturing operations

  • Expert processing equipment knowledge to perform or assist in investigations and CAPA execution

  • Demonstrated understanding of manufacturing processes with ability to trend performance to identify unexpected excursions or trends

  • Develops solutions to complex problems requiring ingenuity and creativity/innovation

  • Ensures solutions are consistent with organization’s objectives

  • Ability to apply investigation and troubleshooting methodology to perform investigations and recommend CAPAs.

Essential for the role:

  • BS/BA degree in relevant field preferred and/or AS degree in relevant field plus experience acceptable

  • Minimum of 5 - 7 years (with Bachelors) biotechnology or pharmaceutical industry experience in process development, manufacturing, or similar role.

  • 8 – 10 years with Associates

  • Deep problem solving skills

  • Strong influencing skills

  • Decision making skills

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, pioneering cutting edge 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 excellent fit, please share this posting with them.

Find out more on Social Media:

LinkedIn https://www.linkedin.com/company/1603/

Facebook https://www.facebook.com/astrazenecacareers/

Instagram https://www.instagram.com/astrazeneca/?hl=en

About Operations https://www.youtube.com/watch?v=gak5Ham8oUw

AstraZeneca has taken critical steps to protecting colleagues, loved ones, and patients from COVID-19 and its variants.  COVID-19 vaccination is required for all US employees, and weekly PCR COVID-19 testing is required for those who are unvaccinated or have an approved accommodation.



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 authorisation and employment eligibility verification requirements.

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