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Lieu: Gaithersburg, Maryland, États-Unis
ID de l'offre 12069534
Date de publication: 05/31/2019

Job Description

AstraZeneca has an opening for a Scientist I in Gaithersburg, MD.  We are seeking a highly motivated upstream tech transfer and manufacturing support professional.  This position will be responsible for transfer of upstream processes from development into clinical and commercial manufacturing.  The position resides within the Cell Culture and Fermentation Sciences (CCFS) department (within Biopharmaceutical 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. 

Responsibilities:

  • Routinely transfer multiple projects as upstream 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, campaign summary report authoring, and routine presentations to cross-functional teams and management
  • Builds and maintains relationships with partner groups
  • Proactively addresses risks/issues and influence process development to avoid non-conformances and enable efficient transfers
  • Effectively communicate and collaborate in a matrix team setting to implement technical solutions. 
  • Represent function on cross-functional teams
  • Perform lab-scale experiments to support process changes, generate robustness data, and/or resolve manufacturing non-conformances
  • Write technical reports and deliver presentations
  • Author and review sections of regulatory filings
  • Contribute to the improvement of the tech transfer business processes through idea generation, team leadership, and implementation
  • Implement new technologies/approaches

Required Skills:

  • Cell culture tech transfer and/or development experience
  • Hands on experience with bioreactors (bench, pilot or production scale)
  • Fundamental understanding of upstream unit operations such as mixing, bioreactor, centrifugation, and filtration. 
  • Working knowledge of the scale-up/scale-down principles of cell culture or fermentation processes
  • Experience with primary clarification via continuous centrifuge
  • Knowledge of GMP manufacturing principles and documentation
  • Identify and solve complex manufacturing or bioprocess technical problems with limited data in a timely manner
  • Skilled in root cause analysis and problem-solving
  • Demonstrated critical thinking skills
  • Excellent written and verbal communication skills
  • Sound decision making with limited data
  • Ability to assess issues and  to make recommendations using sound scientific reasoning
  • Demonstrated initiative and drive for results
  • Demonstrated ability to stand in the face of strong/higher level opposition
  • Must be able to work independently
  • Experience with data and statistical analysis
  • Proven experience in preparing detailed and thorough technical protocols and reports
  • Participates and presents at external meetings

Desirable Skills:

  • Experience in a cGMP-regulated environment and/or large-scale bioprocessing laboratory
  • Fermentation or viral based production experience
  • Skilled in conducting process transfer/process development/technology development projects

Position Requirements

Supervision

This position will not have any direct supervisory responsibilities.


Experience
A Bachelors, Masters or PhD Degree in an engineering or scientific discipline with a focus in a process engineering field (e.g., chemical or biochemical engineering) is strongly preferred. 

The candidate must have industry related experience (BS 10-13, MS 8-10, PhD 3-7 years). 

Additional Notes

Position requires periodic weekend work (cell culture) and/or periodic late night shifts (fermentation).  Position will require 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 law.  AstraZeneca only employs individuals with the right to work in the country/ies where the role is advertised.

Scientist I
MedImmune

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