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WHAT
IN
Scientist I II
Job
MedImmune
US
-
Gaithersburg,
Maryland
Job Code - 02103
Position - See Job Description
Job First Active on: Wednesday, November 04, 2009
APPLY TO THIS JOB (You will be applying directly to MedImmune for this position!)
JOB DESCRIPTION: Scientist I II
Title: Scientist I/II
Location: MD, Gaithersburg - Corporate Headquarters
Req: 02103
Position Summary:
Major Duties and Responsibilities (including supervising others):
Responsible for planning and executing purification process development and optimization for complex novel molecules such as protein-drug conjugates, bi-specific antibodies, fusion proteins, and proteins expressed in E.coli that require re-folding. Candidate is expected to lead or participate in solving challenging protein purification problems such as aggregate removal, protein self association, and glycoform separation. Provides technical expertise in process scale-up and technology transfer to cGMP clinical and commercial manufacturing. Coordinates closely with the analytical biochemistry group and other research and development groups in order to meet project timelines and company goals. Additional job expectations include analyzing and interpreting analytical and process data and understanding the overall project implications of process changes and decisions. Expected to identify new technology and conduct necessary experiments for implementation. Author/reviewer in the preparation of regulatory documents such as INDs, IMPDs, and BLAs. Supervise personnel in the laboratory.
REQUIREMENTS - QUALIFICATIONS: Scientist I II
Special Skills/Abilities:? Theoretical knowledge and practical experience in biotherapeutic purification process development and scale up ? Experience developing protein purification processes for non-Mab molecules such as bispecific antibodies, fusion proteins, and PEGylated proteins.? Experience solving challenging protein purification problems such as aggregate removal, protein self association, and glycoform separation.? Experience with protein modification and conjugation chemistry a plus? Ability to troubleshoot and collaboratively resolve complex problems under tight time constraints? Expertise in protein chromatography and tangential flow filtration? Expertise with the AKTA platform and Unicorn software? Experience writing regulatory documents as well as good oral and written communication skills? Familiarity with process modeling techniques, statistical analysis, and DOE ? GMP experience. Familiarity with tech transfer to pilot and commercial manufacturing desired? Team player and customer focused? Supervisory experience desired Job Complexity: The job is complex, requiring a thorough understanding of the biological and chemical properties of recombinant proteins, process design, and data analyses. Supervision: Reports directly to a Principal Scientist / Associate Director but is expected to work independently on a day-to-day basis. Will supervise B.S./M..S./Ph.D scientists and engineers directly or in matrix(Supervision required, level of independence)
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