Manufacturing Innovation Specialist- Operations
AstraZeneca

Job Info

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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 creates 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.

What you'll do:

• Leading process improvement initiatives (project management) and quality systems management (change controls, deviations, CAPA's, document revisions) with an emphasis on new and innovative technology and/or materials.
  
• Maintaining high level of expertise in biopharmaceutical manufacturing processes and equipment through review of scientific literature and attendance of scientific trainings/conferences.
  
• Conducts independent research, development, or support programs.
  
• Wide application of principles, theories and concepts in biopharmaceutical manufacturing plus working knowledge of other supporting areas.
  
• Actively utilize and champion Lean principles and tools such as problem solving and human performance tools.
  
• Build and maintain strong relationships with key stakeholder such as product development groups as well as customer, corporate and site-based science and technology groups to ensure the desired technology programs are planned and implemented to support Manufacturing Operations' needs.
  
• Primary Manufacturing Operations interface for new technology and new capability projects
  
• Represent the organization as the prime technical contact on programs and projects.
  
• Decisions or recommendations consistently result in project advancement and favorable budget outcomes.
  
• May have frequent collaboration with internal departments (Manufacturing, Engineering, MS&T, SCO, etc.) and outside suppliers of the company to solve process and equipment related problems or implement innovative improvements.
  
• Coordinate's efforts of others within the department or company.
  
• Has some contact with customers and suppliers.
  
• Designing and/or developing inputs for electronic batch records (EBRs).
  
• Reviewing and approving MPRs, SPRs, and EBRs for equipment and procedures used in routine biologics manufacture.
  

Qualifications:

Essential:

• 8-10 years of work experience in process development, pilot plant or commercial biologics manufacturing under cGMP with Bachelors.
  
• 6-8 years experience with Masters degree.
  
• 3-5 years experience with PhD
  

Desirable:

• B.S./B.A./M.S. engineering, biological sciences, physical sciences, or equivalent field of study
  
• Lean/Six Sigma certification preferred.
  

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.

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 a great 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 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.

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