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Sr. Manufacturing Specialist-Operations, Frederick, Maryland

CountryUnited States
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.

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.

Everything we do is to make people's lives better. To us it's personal, as we invent, make, deliver and support. Taking our cutting-edge innovations from our science labs to patients. Fueled by our aspiration to deliver accelerated growth for our company and to make people's lives better, there's never been a more exciting time to shape the next phase of Operations' evolution and growth. We explore, willing to support new ideas, go above and beyond to find better solutions, every day. This is a place for the resilient - hungry for new challenges and diverse opportunities. The driven - willing to learn, take personal accountability and step out of their comfort zone. To build a collective legacy of doing good for people, the environment and society.

Why Join Operations?

Here we turn molecules to medicines, bringing our Research & Development pipeline to life through a rigorous process of development, manufacturing, testing and delivery. In our fast-paced, growing environment, embrace an exciting opportunity to build a long-term, varied career. With a huge variety of global opportunities and learning from other teams this is the place to embrace lifelong learning and build capabilities, setting your own direction and pace.

If you have the passion and the drive to accelerate growth and make people's lives better - then this is the place for you.

What you'll do:

As the Sr. Manufacturing Specialist you will be the process owner/subject matter expert responsible for enabling flawless execution of direct manufacturing personnel.

Major areas of responsibility include the following:
  • Generating and revising of MPRs, SPRs, and EBRs for equipment and procedures used in routine biologics manufacture.
  • Changing control authoring, reviewing, and approvals. Changing control assessment authoring.
  • Validation protocol reviews and approvals
  • Participating in deviation investigations and CAPA identification; drive adherence to standard work and deviation/CAPA closure
  • Implementing innovative technological or efficiency programs/solutions to enable the manufacture of biopharmaceuticals in a high quality, faster and more cost effective manner.
  • Partnering with Quality Assurance to manage quality records and inspection readiness
  • Expert knowledge of biopharmaceutical manufacturing processes, systems and equipment as well as electronic manufacturing and quality systems
  • Knowledgeable of manufacturing automation systems and their application
  • Knowledgeable of application and practices of current Good Manufacturing Practices (cGMP's), international regulatory requirements and guidelines (such as European directives, ICH guidelines and European and Japanese pharmacopeia requirements.
  • Monitors daily operations of a unit and actively assists, or provides direction to, subordinates as required
  • Good organizational skills , First-line management skills for daily operation, Situational Leadership, Decision making skills

Essential for the role:
  • 7-10 years of work experience in process development, pilot plant or commercial biologics manufacturing under cGMP with Bachelors.
  • 5-7 years' experience with Master's degree.
  • 3-5 years' experience with PhD. B.S./B.A./M.S. engineering, biological sciences, physical sciences, or equivalent field of study required. .
  • Good organizational skills
  • Good written and verbal communication skills
  • Proficient with Microsoft Office Applications (Word, Excel, Visio)
  • First-line management skills for daily operation
  • Situational Leadership background
  • Decision making skills experience.

Desired for the role:
  • M.S. or MBA preferred.
  • Lean/Six Sigma certification preferred
  • Previous experience with any of the following applications: Werum PAS|X, SAP, Osi PI, Trackwise QIMS

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 a phenomenal 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