R&D Associate I/II, Purification Process Sciences

Gaithersburg, Maryland

Posted in Pharmaceuticals
about 1 month ago

This job has expired.

Job Description

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 :

In Purification Process Sciences in Gaithersburg, MD you'll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients' lives. We're constantly pushing the boundaries of science to deliver life-changing medicines to patients, with a passion for discovery and a pipeline to show for it. We're pioneering innovative research and exploring novel pathways across key therapeutic areas including oncology, respiratory, inflammation and autoimmunity, cardiovascular and metabolic disease, and infection and vaccines. And we're industry-leading in immunology, protein engineering and translational science. We offer a unique and strong collaborative network as part of the AstraZeneca family, as together we explore synergies between small and large molecules.

Main Duties & Responsibilities :

The position resides within the Purification Process Sciences (PPS) department (within Research and Development). Members of the tech transfer function within this department work closely with the process development scientists (located in the US and UK), clinical/commercial manufacturing organizations, CMOs, and QA to ensure appropriate scale up and transfer of clinical and commercial processes to manufacturing production. Position may require weekend work and/or periodic late-nights (campaign support) and possibly some travel to CMO or other sites (domestic and international).

  • Routinely transfer projects as downstream tech transfer representative including fit-to-plant, process risk analysis, timely generation of tech transfer documentation, batch record review/approval, managing technical relationship between sending and receiving organizations, campaign monitoring and support, performance analysis and interpretation, investigation support, and campaign summary report authoring
  • Conduct small scale process validation studies to support BLA filings
  • Perform lab-scale experiments to support process changes, generate robustness data, and/or resolve manufacturing non-conformances
  • Proactively influence process decisions to help avoid non-conformances and provide input on process development strategies
  • Write technical reports and deliver presentations utilizing sound scientific reasoning and interpretation of the available data and present at internal departmental and cross-functional meetings
  • Builds and maintains relationships with partner group and contribute to the improvement of the tech transfer business processes through idea generation, team leadership, and implementation

Education & Experience Requirements:
A Bachelors or Masters in an engineering or scientific discipline with a focus in a biochemical engineering field (e.g., chemical or biochemical engineering) is required


R&D Associate I: BS with some relevant experience preferred

R&D Associate II: BS with a minimum of 2 years of relevant experience or MS with some relevant experience preferred

Required Skills:
  • Knowledge of downstream unit operations such as affinity, ion exchange, and hydrophobic interaction chromatography, low pH and surfactant-based viral inactivation, virus filtration, and UF/DF (bench, pilot and production scale)
  • Excellent written and verbal communication skills and critical thinking skills.
  • Demonstrated ability to outline issues, assess and present risks/benefits, and ability to make recommendations with limited data using sound scientific reasoning
  • Must be able to work independently and effectively in matrix teams
  • Demonstrating initiative and drive for results

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