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Senior Scientist of Protein Team
Senior Scientist of Protein Team Discussed personally 元
Education: PhD 丨Location: Shanghai
Description of position:

Main duty

This position will function as the technical lead overseeing upstream/downstream process development of therapeutic biologics and product manufacturing. The responsibilities include establishing CMC strategy, scale up, validation batches and CMC regulatory filing.

You will:

-Technical leadership for process development, analytical development, formulation development scale up, validation and manufacturing of biologic drug.

-Support Quality and Regulatory Affairs.

-Author relevant CMC section in regulatory filings and address agency questions.

-Assist in recruiting, training and retaining a high performance team to ensure best quality services and leadership in CMC management functions

 

Qualifications

-Advanced degree (PhD or MS) in BioChemistry, BioChemical Engineering, Life Science or related major with 8+ years of applicable work experience.

-Strategic view and leadership abilities as well as hands on problem solving skills.

-Experience in managing projects is required.

-Experience in two or more functional areas in Project Management, Cell Line Development, Cell Culture, Purification, Analytical, Formulation, Manufacturing, Manufacturing Support, QC or QA in the biologics industry.

-Experience with staff management and/or CMC team management.

-Ability to effectively work across all levels, functions, sites and companies.

-Excellent verbal and written communication skillsin both English and Chinese.

-Familiar with ICH, CFDA drug development regulations, CFDA or overseas experience in biological drug registration is preferred;

JOIN US

Tel:+86-769-86088555-8018

Fax:523808

E-mail:biopharma@fapon.com

Address:3-4th Floor, Building 10, No. 1, Taoyuan Road, Taiwan Hi-Tech Park, Songshan Lake, Dongguan, Guangdong, China

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