Associate Specialist, Clinical Biologics

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 workspaces to suit a variety of working styles while increasing collaboration between teams.   

Summary of the group: 

The Manufacturing Sciences team, based in Gaithersburg, Maryland, is a fully integrated process scale-up and cGMP biomanufacturing function. At our Pilot Plant Facilities, our dynamic clinical manufacturing team performs bioprocessing operations for novel molecules to support the development of new medicines. We produce pre-clinical and early through late-stage clinical drug products that advance AstraZeneca’s biologics pipeline. 

Our integrated team collaborates with our counterparts in technical process development; manages and assures the supply of raw materials; performs non-conformance identification and resolution activities; and provides engineering, technical service, and process automation functions. 

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.  

This role will provide an opportunity to support the startup of a new manufacturing facility.  Once startup activities are completed in 2027 it will transition to 12-hour shift structure in support of a 24/7 operating model for cGMP clinical manufacturing execution. 

Main Duties & Responsibilities: 

• Operates bio-pharmaceutical manufacturing equipment such as incubators, stainless steel and disposable bioreactors, depth filtration skids, chromatography skids, single-use mixers, centrifuges, washers, autoclaves, tanks and in-process testing instruments. 

• Performs steam sterilization, clean in place, manual cleaning and sanitization of equipment 

• Records manufacturing activities clearly and accurately within approved current good manufacturing practices (cGMP) documents and regulatory requirements. 

• Prepares for processing by ensuring equipment and materials necessary are adequate and available. 

• Ensures a safe and environmentally sustainable work environment in accordance with AstraZeneca standards 

• Ability to utilize MS Office tools and AZ enterprise systems 

Education & Experience Requirements: 

Bachelor's degree in a science field with 0-4 years of experience 

Required Skills: 

All stream  

• Introductory knowledge of cell culture operations including Biosafety Cabinet Operation, Bioreactor Operations, aseptic technique and harvest. 

• Introductory knowledge of chromatography, filtration and basic analytical testing (e.g., Protein concentration, osmolarity, pH etc.) 

• Familiarity with basic biology & chemistry concepts. 

• Introductory knowledge of raw material weigh-out and media/buffer preparation.   

• Ability to work with others in a team environment 

Desired Skills:  

• Demonstrates a high level of drive and initiative. 

• Logic and decision-making abilities, critical thinking and troubleshooting skills. 

• Demonstrates flexibility and willingness to change ways of working/identify opportunities to improve processes within cGMP clinical manufacturing environment. 

• Independent and self-starting. Ability to work with minimal supervision. 

Why AstraZeneca?