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Process Lead, Purification- Clinical Biologics

Location Gaithersburg, Maryland, United States Job ID R-149271 Date posted 03/01/2023

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 process lead in the Clinical production team within Biopharmaceutical Development, you’ll build broad knowledge of bioprocessing in a cGMP and process development environment. 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. You will join a collaborative and driven team in an extraordinary biopharmaceutical company.

Main Duties & Responsibilities:

Process execution Subject Matter Authority for their processing area and will represent all shifts and/or functional area as needed for investigations, CAPAs, and receipt of tech transfer information. The position reports to the area director with dotted-line responsibilities to the shift manager to support daily manufacturing activities.

In-direct floor support (50-70% time for support)

  • Representative for investigations and CAPA execution

  • Trend process performance to assess batch performance

  • Review and Approve batch records for manufacturing

  • Assess training proficiency of and provide training to shift personnel

  • Liaison between process scale-up and cGMP with direct influence over process decisions

  • Support process and equipment troubleshooting on the shift, as needed

  • Identify and implement standardized work and process improvements

  • Other duties as assigned or identified

Direct on floor support (30-50% time on shop floor)

  • Proficient and knowledgeable in relevant process operations  

  • Lead on the floor manufacturing execution

Education & Experience Requirements:

Bachelor's degree in a science or engineering field with minimum 4+ years' biotechnology or pharmaceutical industry experience

Required Skills:

  • Work is performed without appreciable direction

  • Applies technical knowledge and expertise to achieve project targets in a timely fashion and to agreed quality standards

  • Develops and maintains a level of scientific knowledge and capability, perhaps extending to specialist expertise in a specific area of work

  • Logic and decision-making abilities, critical thinking and troubleshooting skills; effects of decisions are long-lasting and influence the future course of the organization

  • Contacts are frequent with individuals representing other departments; excellent verbal and written communication skills

  • Contacts involve acquiring or providing information or data on matters of moderate importance to the function of the department or which may be of sensitive nature, requiring some explanation or interpretation

  • Ability to work with others in a team environment and lead a team of peers

Cell Culture

  • Proficient in cell culture operations such as Biosafety Cabinet Operation, Cell Banking, Bioreactor Operations, Aseptic Technique, and Centrifuge Harvest Operations.

Purification and High Containment Suite

  • Proficient in the operation of all area specific production equipment such as column chromatography operations, tangential flow filtration, formulation and column packing

  • Proficient in basic analytical testing (e.g. protein concentration, osmolarity, pH and etc.)

  • Antibody drug conjugates experience preferred

Desired Skills:

  • Dynamic individual with the ability to communicate and engage others.

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

  • Experience in biologics process development and/or cGMP manufacturing

  • Demonstrate a high level of drive and initiative.

  • Helps to develop new and innovative techniques and methodologies for ways of working within area

  • Experience in investigation and troubleshooting methodology

  • Demonstrate leadership, organization and time management skills.

  • Demonstrate flexibility and willingness to change ways of working

  • Continuous manufacturing processing experience

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

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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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Glassdoor logo Rated four stars on Glassdoor

Great culture, great work assignments, supportive management. Rotation opportunity within the company. They value inclusion and diversity.