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Lieu: Gaithersburg, Maryland, États-Unis
ID de l'offre 12421872
Date de publication: 08/02/2019

MedImmune is the worldwide biologics research and development arm of AstraZeneca. Here, you’ll have the opportunity to make a difference in people’s lives every day. As one of the world’s premier biotechnology companies, our mission is centered on delivering life-changing products that advance world health, and help fight and cure disease.  Here at MedImmune, 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.

MedImmune has a dynamic environment that fosters collaboration and innovation. We attract top minds, and we nurture and build top talent.

MedImmune has an opening for an R&D Associate II / Associate Scientist I in Gaithersburg, MD. We are seeking a highly motivated downstream tech transfer and manufacturing support professional. This position will be responsible for transfer of downstream processes from development into clinical manufacturing. 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 manufacturing organizations, CMC teams, and QA to ensure appropriate scale up and transfer of clinical processes to manufacturing production. 

Responsibilities:

  • 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 and manage 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
  • Provide input on process development strategies
  • Write technical reports and deliver presentations utilizing sound scientific reasoning and interpretation of the available data
  • Present at internal departmental and cross-functional meetings
  • Builds and maintains relationships with partner groups

Required Skills:

  • Downstream tech transfer and process development experience
  • Hands on experience with chromatography columns, virus and sterilizing-grade filters, and TFF membranes (bench, pilot and production scale)
  • Fundamental understanding 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
  • Working knowledge of scale-up/scale-down principles
  • Knowledge of GMP manufacturing principles and documentation
  • Demonstrated critical thinking skills
  • Excellent written and verbal communication skills
  • Demonstrated ability to outline issues, assess and present risks/benefits, and ability to make recommendations with limited data using sound scientific reasoning
  • Capable of effectively explaining scientific or engineering concepts to a broad and diverse cross-functional audience
  • Experience with being an effective and influential contributor to projects governed by matrix teams
  • Demonstrated initiative and drive for results
  • Must be able to work independently
  • Experience preparing detailed and thorough technical protocols and reports

Desirable Skills:

  • Experience in a cGMP-regulated environment and/or large-scale bioprocessing laboratory
  • Experience conducting transfer/process development/technology development projects
  • Familiarity with statistical software and Monte Carlo simulations

Supervision

This position will not have any direct supervisory responsibilities.

Education
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. 

Experience

R&D Associate II: BS and a minimum of 2 years of industry related experience or MS and some experience preferred

Associate Scientist I: BS and a minimum of 5 years of industry related experience or MS and at least 2 years of experience

Position may require weekend work and/or periodic late-nights (campaign support) and possibly some travel to CMO or other sites (domestic and international). 

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 great fit, please share this posting with them.

AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by lawAstraZeneca only employs individuals with the right to work in the country/ies where the role is advertised.

R&D Associate II / Associate Scientist I, Purification Process Sciences – Tech Transfer
MedImmune

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