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发帖数: 95 | 1 We are a Biotech/Pharmaceutic company develop novel vaccines for
inflammatory diseases including rabies and influenza, et al. Currently we
are looking for a qualified individual to fill the position of: Sr.
Scientist, Upstream Process Development.
RESPONSIBILITIES:
1.Be responsible for planning, execution and management of all upstream
Vaccine manufacture processes;
2.Plan workload and generate experimental plans and final reports for all in
-house developed upstream processes. Assist in the internal technology
transfer between Process Development and Manufacturing.
3.Implement process controls and test methods to ensure that final quality
products are scaled-up and manufactured in a reproducible manner.
4.Provide expertise and troubleshooting for all in-house developed processes.
5.Prepare and review all relevant regulatory documents (INDs, CMCs) to meet
development and manufacturing objectives and timelines.
Main Accountabilities:
1.Leads the project and produces high quality product in a timely manner.
2.Complies with cGMP regulations for making recombinant protein products for
pre-clinical, and phase I/II clinical trials in animals and humans.
Completes all required GMP and safety training.
3.Promotes work in a team setting and creates positive work climate.
Interacts with other departments involved in GMP manufacturing for planning
production, testing and product release in a timely manner resulting in
successful completion of projects.
4.Anticipates problems especially those that may compromise the quality of
the product. Analyzes situation and develops action plan for the successful
completion of the project.
5.Oversees day-to-day operations of the Process Development and
Manufacturing Purification labs. Maintains constant supply of materials,
maintenance services etc. for the efficient function of the labs.
6.Demonstrates leadership. Communicates all matters of importance to the
supervisor and to the members of the team for prompt action.
Knowledge and Experience Required:
1.This position requires a Ph.D. in a life science discipline (Molecular
Biology, Microbiology or other), with 5 years of experience or MS degree
with 9 years of in Upstream Process Development and / or cGMP Manufacturing
under cGMP compliance.
2.Previous experience with single-use bioreactor and Rabies Vaccine
development is a plus.
Please send message to me requesting how to apply. |
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