Language·Chinese
Director of Cell Culture
2018-06-01

<!--[if !vml]--><!--[endif]-->Job Description

 

Position: Senior Director / Director of Cell Culture

 

Report to: Development VP

 

Base: Open to discuss

 

Language: Chinese & English

 

Accountabilities:

<!--[if !supportLists]-->r  <!--[endif]-->Playing leadership with a focus on building strong and productive teams.

<!--[if !supportLists]-->r  <!--[endif]-->Keep current on cell culture method innovation development in the Pharmaceutical/Biotech industry.

<!--[if !supportLists]-->r  <!--[endif]-->Leading cell line and culture processes development for the production of biologics, especially antibody drug development

<!--[if !supportLists]-->r  <!--[endif]-->Responsible for cell culture process scale-up/process characterization, and cell banking / method development

<!--[if !supportLists]-->r  <!--[endif]-->Responsible for cell culture process scale-up and scale down, and trouble shooting

<!--[if !supportLists]-->r  <!--[endif]-->Implementation of the cGMP requirements of manufacturing processes for biopharmaceuticals

<!--[if !supportLists]-->r  <!--[endif]-->Managing CRO and CMO, technology transfer to manufacturing sites, authoring of CMC sections for regulatory filings, including IND, BLAS/MAA

<!--[if !supportLists]-->r  <!--[endif]-->Coordinating internal and external projects and team communication

<!--[if !supportLists]-->r  <!--[endif]-->Developing QbD approaches and Control Strategy for cell culture process.

<!--[if !supportLists]-->r  <!--[endif]-->Serving as a leader in CMC team.

 

Qualifications:

<!--[if !supportLists]-->r  <!--[endif]-->Ph.D. in biological chemistry or chemical engineering or related fields

<!--[if !supportLists]-->r  <!--[endif]-->8+ years in cell culture process development in biopharma industry

<!--[if !supportLists]-->r  <!--[endif]-->Excellent communication skills and ability to work with internal and external matrix teams

<!--[if !supportLists]-->r  <!--[endif]-->Experienced in authoring and review of IND, BLA & MAA drug substance

<!--[if !supportLists]-->r  <!--[endif]-->Detailed knowledge of Process Validation requirements and working knowledge of PAT tools

<!--[if !supportLists]-->r  <!--[endif]-->Demonstrated mastery of handling large sets of data including statistical analysis using software packages such as JMP; SIMCA, etc.

<!--[if !supportLists]-->r  <!--[endif]-->Knowledgeable on multivariate analysis and DoE approaches, and raw material supply chain and logics issues, vendor auditing experience as plus

<!--[if !supportLists]-->r  <!--[endif]-->Excellent communication skills in both Chinese and English, written and orally are required.

 

 

TAYU-BIOTECH Introduction:

 

TAYU Biotech group was established in September 2016, which is committed to develop innovative immunotherapy drug in China founded by Professor Chen Lieping who is a global famous immunologists and oncologists.

Professor Chen Lieping is the world’s leading investigator in the characterization of cell surface co-stimulatory and co-inhibitory molecules that modulate immune responses. He is professor of immunobiology, of dermatology, and of medicine (medical oncology) at Yale School of Medicine and director of the cancer immunology program at the Yale Cancer Center. Professor Chen is the first scientist to apply co-stimulation as a mean for cancer immunotherapy. His laboratory discovered immune suppressive function of the B7-H1 (PD-L1)/PD-1 pathway in cancer and first demonstrated using antibody to block this pathway to enhance tumor immunity for the therapy of cancer. The anti-PD-1 and anti-PD-L1 has been well recognized as the most safe and effective drugs for the therapy of cancer so far.

With rich experienced R&D team, TAYU is developing anti-tumor drug including immune checkpoint inhibitors, co-stimulus antibodies, dual specificity antibodies and biomarker etc. TAYU group will strive to grow into a top biopharmaceuticals group that covers research and development, transformation, and manufacture in the future.

 

Contact information:

Address: 8-2 Dongdan Santiao, Dongcheng district, Beijing, China

Tel: +86 10 67177097

E-mailclara@tayubiotech.com



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