Associate Scientist II / Scientist I, BioProcess Engineering - Upstream – (Gaithersburg, MD)
Location:
Gaithersburg , Maryland
Posted:
December 16, 2017
Reference:
R-014217
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 an Associate Scientist II/Scientist I 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 ResponsibilitiesAs the Associate Scientist II/Scientist, you will be responsible for scale up and transfer of clinical and commercial processes to manufacturing.  Members of the upstream process engineering team work closely with the upstream process development groups (located in the US, CA and UK) and manufacturing group to provide upstream process engineering and tech transfer support across all stages of upstream process development (from Toxicology lot production through production of lots to support BLA filings).  This position provides support to process engineering and technology transfer.  You will transfer upstream processes from Cell Culture and Fermentation (UK and US) sites into clinical and commercial manufacturing sites, either CMO or internal.  Perform process manufacturing assessment including fit-to-plant assessment and process risk analysis.  Ensure timely execution of tech transfer activities in order to meet project timelines.  Review and approve manufacturing batch records.  Manage technical relationship between sending and receiving upstream organizations.  Monitor and support manufacturing processes real-time in the manufacturing facility.  Review, trend, analyze, and interpret manufacturing data from ongoing production campaigns to ensure consistent product quality and process performance. Identify and solve complex manufacturing or bioprocess technical problems with limited data in a timely manner.  Effectively communicate and collaborate in a matrix team setting to implement technical solutions.  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 utilizing sound scientific reasoning and interpretation of the manufacturing campaign summary reports, technical support studies, and regulatory filings such as INDs and BLAs.  Routinely present experimental findings to cross-functional teams.  Support application of QbD approaches in manufacturing.  Also, you will participate in the development and implementation of tools to improve process predictive tools to map upstream processes into clinical and commercial facilities.  Develop and qualify scale-down models for mixing, cell culture, and harvest unit operations.    Develop or investigate new equipment, upstream process technologies, and upstream process controls for feasibility to implement across laboratory, pilot and commercial scale production. Interface with Quality, Engineering, Validation, Manufacturing, and Development to solve production issues and to ensure manufacturing process equipment meets quality standards and is acceptable for use in clinical and/or commercial manufacturing. Apply scientific and engineering principles, theories and concepts to assist investigation, scale-up specification, and process controls of upstream operations such as medium preparation, mammalian cell culture, and primary clarification. Proposes solutions to a wide range of difficult problems, requiring creative thinking skills and typically conducts more than one project at a time. Responsible for participating in matrix teams of scientists and engineers focused on process engineering and technology development/implementation projects.  Present at internal departmental and cross-functional meetings.  Participates and presents at external meetings.  Responsible for meeting project goals within time and resource constraints.  Able to make decisions based on limited amount of data and comfortable with presenting ideas and data to senior leadership.
Essential Requirements
Associate Scientist II:
  • The Associate Scientist II candidate must have industry related experience (BS 8-10, MS 5-8 years).  
Scientist I:
  • The Scientist I candidate must have industry related experience (BS 10-13, MS 8-10, PhD 1-3 years).
Both:
  • Industrial experience supporting clinical or commercial biotechnology is preferred. 
  • Experience with GMP equipment design and use of data management systems is desired but not required.  
  • Demonstrated leadership through project team participation, internal consulting, and mentoring.
  • A Bachelors, Masters or PhD Degree in a scientific or engineering discipline with a focus in a process engineering field (e.g., chemical or biochemical engineering) is strongly preferred.  Desirable Requirements
Desirable Requirements
  • Must be able to work independently.
  • Fundamental understanding of upstream unit operations such as mixing, bioreactor, centrifugation, and filtration.  Experience with operating bench, pilot, or production scale reactors/fermenters is required.  Working knowledge of the scale-up/scale-down principles of cell culture or fermentation processes is essential. 
  • Knowledge of GMP manufacturing principles and documentation is desired.
  • Knowledge of the drug development process, global regulations, process validation and ICH guidelines is desired. 
  • Skilled in conducting complex research projects.
  • Skilled in root cause analysis and problem-solving.
  • Skilled in effectively explaining complex scientific or engineering concepts to a broader, diverse, cross-functional audience.
  • Experience with data and statistical analysis are required.
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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*LI-MEDI

A little about us:
MedImmune is the global biologics research and development arm of AstraZeneca

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