MedImmune Scientist II- (Gaithersburg, MD) in Gaithersburg, Maryland

If you're inspired by the possibilities of science to change lives and you thrive when making brave decisions -- join us.

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. As a Scientist II or Manager 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.

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

Main Duties and Responsibilities

This position can be filled at either the Manager or Scientist II level depending upon experience and career track applicability/preference.

You will perform process development and tech transfer for late-stage biopharmaceutical drug products in combination product formats (PFS, cartridge, and related devices). You will contribute to Drug Product development strategy on project teams by providing knowledgeable advice on process design options, manufacturing site alternatives, project lead time and budget estimates. You will advise functions and teams on new manufacturing technology selection and development, as well as develop risk-based characterization and validation strategies for novel manufacturing processes.

In addition, you will carry out device assembly process development activities for late-stage projects. Develop assembly, label and packaging processes, perform process risk assessments such as FMEA, design characterization and engineering studies, author protocols, technical reports and regulatory filing sections. You will provide technical rigor in experimental design, data analysis, and technical writing, develop pilot laboratory assembly process capabilities appropriate to supply materials for device testing needs in the Drug Product development process, and perform laboratory tests to evaluate device failure modes associated with manufacturing and shipping.

Finally, you will lead late-stage and commercial technical transfer of device assembly, label and packaging processes to CMOs and internal fill facilities for biopharmaceutical drug products. You will organize an internal sending unit team including development functions (formulation, process, device, analytical, packaging), supply chain, project management and QA. You will design and oversee validation activities for equipment, manufacturing processes, and shipping of drug product, manage timelines and activities internally, communicate goals and oversee successful delivery at the receiving site. Some travel (5-15 trips per year) in the US and abroad is required.

Essential Requirements

  • Scientist II: BS with eight years of industry experience, or MS with six years of industry experience, or PhD with three years of industry experience

  • Manager: BS with eight years of industry experience, or MS with six years of industry experience

  • Educational requirements include a degree in mechanical, chemical, or pharmaceutical engineering, chemistry, or a related engineering or pharmaceutical science field

  • Biopharmaceutical / combination drug product development

  • Combination product and cGMP regulations

  • Assembly, label and packaging processes and equipment

  • Equipment, Process and Shipping Validation

  • Biopharmaceutical degradation pathways in a manufacturing setting

  • QbD, experimental design, statistics, data analysis

  • Suitable experience may include development of combination products and/or associated manufacturing processes, or cGMP manufacturing or validation of device assembly processes

Desirable Requirements

  • Leadership and interpersonal communication

  • Tech transfer experience or experience organizing and leading cross-functional teams

  • A high degree of self-motivation, mechanical skill and scientific rigor

  • Ability to handle multiple ongoing work streams in an organized fashion

  • Technical writing and documentation

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 law. AstraZeneca only employs individuals with the right to work in the country/ies where the role is advertised.

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