Senior Scientist, CAR-T/NK Process Development

Key Responsibilities:

Senior scientist will scientifically lead a team responsible for process development of CAR-T or CAR-NK products.

He/she will lead highly technical team to design and develop manufacturing process for autologous or allogeneic cell therapy products.

The candidate will interact with program groups (mainly including liquid/solid tumor R&D groups, vector group, QC group and clinical team) and drive the strategy to develop engineered T or NK cell products in the pipeline.

The candidate will direct activities to develop drug substance process in a cross-functional matrix team including the design of experiments, execution of the planned experiments, optimization of the process steps, scale-up to the target process scale for early and late stage products and product manufacturing for clinical trials.


Additional responsibilities include but not limited to the following:

Leads a team responsible for the design and execution of development studies to identify and determine appropriate ranges of critical process parameters for drug process.

Participates or takes a lead role in a cross-functional team to transfer technology to cGMP manufacturing partners or US CMC team.

Writes and reviews protocols, SOPs, technical reports, regulatory documents and memos to summarize experiments and investigations.

Interacts with internal cross-functional team members including QA, Regulatory, Legal, Operations and Discovery.

Works effectively in a team environment as well as contributing individually as well as scientifically leading the team to meet project timeline and objectives.

Preparation of CMC sections for regulatory submission (IIT, IND, BLA) in collaboration with other departments.

Other duties will be assigned, as necessary.


Qualifications:

Ph.D. in Cell Biology, Immunology, Biochemical Engineering or related fields OR MS in Cell Biology, Immunology or Biochemistry with at least 5 years of relevant experience. Experience in the development of cellular and gene therapies is preferred.

Knowledge in cell biology and immunology are required (strong background in T or NK cell biology is preferred).

Strong background in a variety of biological assays such as FACS, cytotoxicity, proliferation, ELISA, qPCR.

Familiarity with and hands-on experience with analytical methods typically used in the manufacture and characterization of biological products is preferred.

Experience maintaining written records of work in the form of laboratory notebooks (paper or electronic) required.

The strong ability to edit data, report data, present findings to management is required - Experience with team-based collaborations or scientifically direct management of staff is required.

Ability to manage priorities, and make decisions in a fast-paced environment to make sure deliverables are achieved in a timely fashion.

Excellent communication skills both in English and Chinese.

Occasional domestic or international travel will required.

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最近在线时间：2022-05-03 23:05

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地址：欧洲/中欧/德国

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