Senior Research Associate

必須

• Advanced degree in biology or engineering with 3+ years relevant biopharmaceutical industry experience or experience in academia
• Wet lab experience with aseptic technique
• Experience working semi-independently to design and perform scientific experiments to develop and/or evaluate new technologies
• Excellent communication skills
• Successful experience working cross-functionally across multiple departments including Research, Manufacturing, and Quality.
• Excellent and effective written, verbal communication and presentation skills.
• Business level English

歓迎

• Prior rAAV gene therapy experience
• Prior downstream process development experience and/or experience of samples of process development, like ddPCR, ELISA, ultracentrifuge, LC-MS and other analytical devices
• Ability to communicate with colleagues abroad in English
• Experience with authoring IND, CTA, and other related regulatory filings and responding to Agency feedback/inquiries
• Business level Japanese

求める人物像

• Able to work in a fast-paced and dynamic environment with competing priorities
• Seeks opportunities to improve existing processes and drive large-scale change that positively impacts organizational success.
• Positive, professional attitude with a passion for science.

使用ツール

募集の背景 / Purpose & Scope

• The Senior Research Associate, Process Science, is responsible for activities for new technology development, not related with specific project/programs, but be applicable to current and future clinical trial manufacturing process of our rAAV to support growing and diversifying portfolio of Astellas’ Cell and Gene Therapy Research pipeline. S/he designs and performs experiments mostly by her/his own with some help with colleagues in the team appropriately. S/he makes presentations internally or out side of the company as poster and/or oral presentations to discuss the results of the experiments scientifically.

雇入れ直後

• Perform experiments and evaluations of new technologies to enable/maintain Astellas’ place as a leader in rAAV manufacturing with some help if necessary
• Produce scientific data to propose new technologies that meet or exceed target quality profiles, yields, productivity, COGs, and other identified attributes for future manufacture process of rAAV
• Evaluates novel and innovative technology applicable to improve AAV product quality and/or productivity
• Performs design of experiment investigations using software tools for design and data analysis
• Responsible for understanding and applying data generated from experiments and literature used to modify/optimize process parameters
• Assists in the development of robust and cost-effective commercial scale production processes.
• Writes protocols, development reports, and other technical reports to ensure that results are properly archived and communicated
• Ensures safe and compliant laboratory safety procedures are followed
• Regularly presents data, findings and conclusions to program teams and sub-teams
• Proactively collaborates with consultants and internal stakeholders.

変更の範囲

• 会社内での全ての業務

就業環境に関する要件 / Specific Physical or Environmental Requirements

• This position is based in Tsukuba Miyukigaoka and will require on-site work.
• This position has responsibilities for advancing new technologies and processes for rAAV manufacturing. This position will be in charge of evaluating new technology development that is tied with some of divisional and/or organizational goals.
• This position reports to the Head of Process Science.