JD of Lead Application Scientist

Job Description

Position Title
职位 / Biomanufacturing Lab technician
生物制药实验室技术员
Employee Chinese Name / Employee English Name
Business / GEHC LS / Function / Fast Trak / Location / Shanghai
Band / PB / Starting Date

Description:

Work in 200L pilot scale clean room for biosimilar MAB pilot scale pre-clinical manufacturing. Prepare MAB drug in non-GMP condition for PK/PD and tox animal study.

Essential function/Responsibility:

1.  Operate single use MAB production line, including 10L-200L bioreactor, lab to manufacturing purification chromatography system, UF/DF, harvest, Nano-filtration.

2.  Review technical transfer documents and update batch records according to customer’s process.

3.  Execute pilot scale upstream cell culture process or downstream purification process according to SOPs and Batch Records.

4.  Assist scientists to execute lab scale research and development, either cell culture or purification.

5.  Prepare cell culture media and purification buffer.

6.  Manage material, equipment and other facility (water, power and gas)

Required Qualification

1.  Bachelor above, major in Biochemical, Pharmaceutical, Medicine, Biology, Bacteriology, or equivalent.

2.  At least 1 year working experience in biopharmaceutical industry, either pilot plant or GMP manufacturing plant.

3.  Operation experience in clean room, accoring to SOPs and batch records.

4.  Good hand on work skills in single use bioreactors, chromatography systems, bags, tubing connector, filters.

5.  Understand GMP operation requirement.

6.  Willing to learn new technology and develop your self to be a scientist or project manager in biopharm filed.

7.  Excellent writing and reading skills in English and Chinese.

8.  Excellent computer skills for document management.

Preferred Qualifications:

·  Master degree in relavant filed or 3+ years industrial experience in GMP biopharmaceutical manufacturing.

·  Experience in preparing IND and NDA documents.

·  Proven excellence in communication, presentation and facilitation skills.

·  Demosntrated ability to deliver results while working on multiple project simultaenously, in a cross-functional team in an international enviorment.

Desired Qualification

·  Enthusiastic, optimistic, self-motivated achiever.

·  Intelligent, in-depth technical approach.

·  Reliable and thorough person who always delivers on promises and always promises realistically.

·  Good organizational skills.

Direct Manager’s Signature Employee’s Signature

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Date Date

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