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系，会陆续有R&D,Clinical等职位open
Title:（Sr.)Scientist, Upstream Process Development
Report to: Sr. Principal Scienitst, China R&D
Subordinates: 2-4
I. General job accountability:
This individual functions independently and productively as an Upstream
Process Development scientist and is actively engaged in process and product
development within a dynamic project team. Displays strong technical
knowledge, initiative and scientific commitment, and makes significant
scientific and technical contributions within Process Development Group.
• Develop robust, high-producing, scalable and economically viable
cell culture production processes.
• Develop, optimize and scale-up fed-batch bioreactor processes. Lead
efforts to evaluate different cell culture media and feed formulations.
Evaluate optimal feeding strategies to improve product yield, quality and
purity.
• Perform and analyze Design of Experiment (DOE) studies to fully
characterize processes. Support process validation studies and activities.
• Provide input on the evaluations of contract manufacturers and
research organizations.
• Manage direct reports to execute all process development activities
to meet aggressive timelines.
• Collaborate and coordinate with colleagues from basic research,
downstream purification, analytical development, manufacturing, QA and QC
teams.
II. Qualification and competency requirements：
A. Education /Training background:
PhD with 0- 3 years related experience, MS with 2- 4 years related
experience.
B. Knowledge/Skills:
• Experience with developing fed-batch bioreactor processes including
optimizing feeding strategies and evaluating different cell culture media
and feed formulations.
• Hands-on experience with CHO and other mammalian cell for mAb or
recombinant protein production.
• Experienced in process optimization, scale-up and technology
transfer.
• Previous experience in process development and optimization using
statistical tools is (DOE and data analysis) is desirable.
• Knowledge of process characterization and process validation of
biological products is a plus.
C. Others:
• Excellent organizational and planning skills in order to meet
deadlines and to handle multi tasks.
• Diligent, self motivated, independent, strong sense of
responsibility.
• Excellent written and verbal communication skills in Chinese and
English.
• Good interpersonal skills for building relationships across
functions internally and expternally. |
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