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summary
about the company.
is a leading CDMO that enables its partners’ success in biologics. By leveraging our innovative R&D and manufacturing capabilities, we empower the entire biologics processes – from cell line development to commercial manufacturing – enabling customers to deliver affordable and accessible biologics that benefit patients worldwide.
...
skills and experience required.
1. MS degree or above in Chemical/Biochemical Engineering, Biochemistry,
Cell Biology, or related discipline with at least 8 years of experience focused
on mammalian cell culture process development and scale-up for the
production of therapeutic proteins. Ph.D. degree is preferred.
2. Excellent oral and written communication skills in English and Mandarin
(Read, Write, Verbal) demonstrated by communicating with other functions,
management team and clients
3. Familiarity with laboratory procedures and operations including set up and
operating shake flasks , lab scale bioreactors and pilot scale disposable
bioreactors and associated analytical equipment used for mammalian cell
culture processes.
4. Experience with scale up, medium selection and process optimization
5. Experience with authoring IND, CTA, and BLA regulatory documents is a
plus.
about the company.
is a leading CDMO that enables its partners’ success in biologics. By leveraging our innovative R&D and manufacturing capabilities, we empower the entire biologics processes – from cell line development to commercial manufacturing – enabling customers to deliver affordable and accessible biologics that benefit patients worldwide.
about the job.
1. Supervise and lead cell culture team including Process Development (PD)
and Manufacturing Science & Technology (MSAT) to development cell culture
process (CHO, NS0, and other systems)
2. Lead the scale-up of cell culture process to pilot scale (200L/500L) as well as
commercial scale (500L, 2000L or larger)
3. Lead the process transfer from clients to CBL, or from PD team to
manufacturing
4. Lead all the troubleshooting activities on cell culture process development
and manufacturing related issues
5. Act as the SME on cell culture process, and lead the deviation investigation
related to cell culture manufacturing process
6. Write, review and approve protocols, procedures, reports, batch record and
other process related documentation as necessary to support GMP
...
skills and experience required.
1. MS degree or above in Chemical/Biochemical Engineering, Biochemistry,
Cell Biology, or related discipline with at least 8 years of experience focused
on mammalian cell culture process development and scale-up for the
production of therapeutic proteins. Ph.D. degree is preferred.
2. Excellent oral and written communication skills in English and Mandarin
(Read, Write, Verbal) demonstrated by communicating with other functions,
management team and clients
3. Familiarity with laboratory procedures and operations including set up and
operating shake flasks , lab scale bioreactors and pilot scale disposable
bioreactors and associated analytical equipment used for mammalian cell
culture processes.
4. Experience with scale up, medium selection and process optimization
5. Experience with authoring IND, CTA, and BLA regulatory documents is a
plus.
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