职缺一: Protein purification Sr. Scientist
Responsibility:
1. Lead a team of scientists and engineers and be responsible for the
management of at least one purification development project.
2. Well communicated with upstream and QC/QA to cooperate to write and
review the development reports, validation protocols and reports.
3. Lead or participates as a purification representative in
inter-departmental teams and senior management meetings
4. Demonstrate ability and experience in managing groups of people.
Motivates and supports the career development and technical
expertise of reports. Regularly meets with, sets clear goals
and expectations, and provides timely feedback to reports.
Hires the best people available.
5. Understand procurement process in the process development lab
6. Review data and lab books
7. Monitor raw material ordering and equipment maintenance schedule
and its calibration
Education and Experiences requirements
1. At least B.S. or higher in biochemistry, biology, or chemical
engineering or related fields
2. At least 5 years experiences in purification process development
including familiarity with process of chromatography, filtration
and manufacturing operations
3. An understanding of cGMP requirements and their application to
development and operations is desirable
4. Familiar with the essential protein analytical tools likes:
HPLC, SDS-PAGE, ELISA, Western, protein assay …, etc.
5. Know why and when to use different tools to facilitate process
development to differentiate QC data
6. Effective communicator of ideas, project goals and results
Be creative and motivated
职缺二: Cell Culture Sr. Scientist
Responsibility:
1. Requires a PhD in Chemical/Biochemical Engineering, Biochemistry,
Cell Biology, or related discipline and 1+ year of relevant experience
or a Master degree in related discipline with 4+ years of relevant
experience
2. Strong Scientific and Engineering expertise developing novel upstream
mammalian cell culture processes for the generation of monoclonal
antibody and recombinant protein therapeutic products.
3. Expertise in optimization of cell culture processes to manipulate
product quality characteristics as well as productivity
4. Experience with CHO-based expression systems highly desirable
5. Extensive hands-on expertise with laboratory procedures and operations
including set up and operating shake flasks, lab scale bioreactors and
pilot scale bioreactors and associated analytical techniques used for
mammalian cell culture processes
6. Experience with single use bioreactors (SUBs) highly desirable
7. Expertise leading media and feed development, scale-up, technology
transfer and process validation activities
8. Experience with cGMP’s highly desirable
9. Experience authoring IND, CTA, and BLA regulatory documents highly
desirable
10. Excellent written, oral and organizational skills
11. Detailed knowledge and experience in developing submission strategy
and regulatory filing.
12. Written and oral communication in Mandarin and English are essential.
Education and Experiences requirements
1. Design, execute and evaluate laboratory-scale cell culture experiments in
order to develop robust processes suitable for GMP clinical and commercial
manufacturing
2. Process development scope includes clone screening in bioreactors, media
and feed development, defining optimal ranges for bioreactor operation
and control parameters
3. Develop phase-appropriate characterization and validation strategies for
the developed processes
4. Implement sound statistical DOE-based studies for efficient process
optimization and characterization
5. Seek out, evaluate, and implement new technologies to optimize efficient
development of cell culture processes
6. Develop and maintain necessary process development documentation standards
including process development reports, technical transfer reports, and
characterization and validation protocols, as well as laboratory equipment
data capture and storage.
7. Support process transfer into manufacturing and lead process validation
at scale
8. Write and revise protocols, procedures, reports and other process related
documentation as necessary to support GMP manufacturing operations
9. Author cell culture sections of regulatory submission documents for
world-wide health authorities
Interested candidates please send your Chinese/English resume to
shsiao@jhlbiotech.com 萧小姐
Please feel free to PM me if interested.
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有问题可以站内信问我