Associate Specialist
AstraZeneca

Do you have a passion for science? Would you like to apply your expertise to impact a company that follows the science and turns ideas into life changing medicines? Then AstraZeneca might be the one for you!

At AstraZeneca, we put patients first and strive to meet their unmet needs worldwide. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. If you are swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you're our kind of person.

About AstraZeneca in Gaithersburg, MD:

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. This modern and vibrant scientific campus is the home of R&D and Oncology in the US. Here, we play host to some of the most cutting-edge technology and lab spaces, all designed to inspire collaboration and cross-functional science. We believe employees benefit from being challenged and inspired at work. We are dedicated to creating a culture of inclusion and collaboration. 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.

Summary of the group:

As a pilot production associate in the Clinical production team within Biopharmaceutical Development, you'll build broad knowledge of bioprocessing in a cGMP environment to launch your career in the biopharmaceutical industry. In this role you will take an adaptable, science driven approach to everything you do. You will become an integral part of process development, accelerating product candidates into the clinic and gaining knowledge and experience in cell culture, purification and critical support activities. Under the supervision of highly trained personnel, you will gain the process knowledge and skillsets to perform large scale clinical development activities through hands-on training. You will join a collaborative and driven team in a world class biopharmaceutical company that is driving disruptive innovation in the industry

Main Duties & Responsibilities:

• Operates bio-pharmaceutical manufacturing equipment such as: incubators, stainless steel and disposable single-use bioreactors, depth filtration skids, LN2 Dewar's, chromatography skids, single-use mixers, centrifuges, washers, autoclaves, tanks and in-process testing instruments.
  
• Performs SIP, CIP and manual cleaning and sanitization of equipment
  
• Monitors critical process parameters and troubleshoots equipment during processing.
  
• Documents all manufacturing activities clearly and accurately per cGMP and regulatory requirements.
  
• Prepares for processing by ensuring equipment and materials necessary are adequate and available.
  
• Ensures all production activities are completed in an aseptic, safe and compliant manor.
  
• Interacts regularly with co-workers, senior personnel and supervisors in dynamic team environment to improve quality and process efficiency
  
• Ability to utilize MS Office tools such as Excel, WORD, Power Point, SAP etc.
  
• EM and CVS
  

Education & Experience Requirements (for external use only):

Bachelor's degree and 0-2 years' experience OR Associates degree and 1-4 years' experience

Required Skills:

Downstream

• Introductory knowledge of Column Chromatography process operations, column packing TFF (Tangential Filtration Flow) and basic analytical testing (e.g., Protein concentration, osmolarity, pH etc.)
  
• Introduction to antibody conjugation process and manual operation in a glove box isolator unit.
  

Upstream

• Introductory knowledge of bioreactor operations including media charge, inoculation, and harvest.
  

Support services

• Weigh and checks raw materials, assemble and clean process equipment, monitor processes
  
• Perform SIP, CIP and manual cleaning and sanitization of equipment
  
• Preparation and filtration of production scale buffer and media solutions.
  
• Operate area specific production equipment such as glass washers, autoclaves, fixed and portable stainless steel tanks, etc.
  

All stream

• Introductory viral process knowledge.
  
• Introductory knowledge of disposable bioreactor operations to include RM table top bioreactor set up and operation up to 500L scale. Aseptic technique and cell banking operations.
  
• Introductory knowledge of harvest set up and operations using POD filters.
  
• Downstream process introduction to include column packing, column chromatography using AKTA skid, tangential flow filtration, ultrafiltration/diafiltration, ultracentrifuge and bulk fill operations.
  
• Introductory knowledge of raw material weigh-out and media/buffer preparation.
  

Desired Skills:

• Serve as a trainer for the CIP, P-Test, and SIP of product hold tanks
  
• Serve as a trainer in Column Chromatography process operations, column packing, TFF (Tangential Filtration Flow) and basic analytical testing (e.g., Protein concentration, osmolarity, pH etc.)
  
• Serve as a trainer for bioreactor operations including media charge, inoculation, and harvest.
  

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 recognising their potential. Join us on our journey of building a new kind of organisation 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.

So, what's next!

Are you ready to bring new ideas and fresh thinking to the table? Brilliant! We have one seat available and we hope it's yours.

Where can I find out more?

Check out our landing page for more information on our BPD group https://careers.astrazeneca.com/bpd

Our social media, Follow AstraZeneca on LinkedIn https://www.linkedin.com/company/1603/

Follow AstraZeneca on Facebook https://www.facebook.com/astrazenecacareers/

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