Process Development Scientist - Gene Therapy Technique 3124625 (职位编号:3124625)
GE医疗集团
- 公司规模:5000-10000人
- 公司行业:医疗设备/器械
职位信息
- 发布日期:2019-01-17
- 工作地点:上海
- 招聘人数:1人
- 工作经验:无工作经验
- 学历要求:硕士
- 职位类别:其他
职位描述
Essential Responsibilities
1. Ensure all routine lab operations compliant with GE EHS guidance.
2. Offer process development services for Gene Therapy accounts by establishing and maintaining an active lab in Shanghai, including virus production and related analytical methods.
3. Draft and update continuously for all SOPs related to lab operations.
4. Train commercial team in specific virus production processes and applications.
5. Collaborate with commercial team to promote GE platform for virus manufacturing workflows.
6. Support sales activities in house and/or at the customer sites.
7. Keep close communication with global or local regulatory authorities regarding Gene Therapy guidance.
8. Present at scientific conference and/or in front of customers as needed.
9. Support publication of gene therapy application notes.
10. Understand marketing trends to support sales department and customers.
11. Able and willing to travel up to 20% of the time.
Role Summary/Purpose
The gene therapy process development scientist will be responsible for developing technical solutions for gene therapy manufacturing process, including mammalian cell culture, clarification and virus purification. Establish and maintain one active lab to deliver process development and technical trainings for both internal & external people. Collaborate with global CGT team and local commercial team to promote industrialized GTT solutions by GE GTT platforms.
Qualifications/Requirements
• Master degree with 5+ years industry experience or Ph.D. degree with 2+ years industry experience.
• Strong upstream technical background on mammalian culture, including culture medium screening & optimization, stirred-tank bioreactor expansion and the following clarification.
• Strong downstream technical background about virus purification by chromatography and filtration-based techniques.
• Has in-depth understanding for Quality control related to virus manufacturing flow.
• Familiar with related latest regulations, CFDA, FDA and EMEA.
• Has good knowledge about Good Manufacturing Practices (GMP).
• Experienced with DoE and other high throughput tools to implement QbD in process development.
• Good presentation and interpersonal skills, self-direction, people-oriented, proactive, good planning & execution skill, sense of responsibility, fast learner and team player.
• Good scientific writing and oral presentation skills.
• Fluent in English/Chinese (reading/speaking/writing).
Desired Characteristics
• Customer focused, commercially aware.
• Previous experience in an actual client-facing process development role.
• Excellent computer skills for document management.
• Enthusiastic, optimistic, passion self-motivated achiever.
• Reliable and thorough person who always delivers on promises and always promises realistically.
• Good organizational skills.
• Good team work with team members and local commercial team.
About Us
GE is the world's Digital Industrial Company, transforming industry with software-defined machines and solutions that are connected, responsive and predictive. Through our people, leadership development, services, technology and scale, GE delivers better outcomes for global customers by speaking the language of industry.
1. Ensure all routine lab operations compliant with GE EHS guidance.
2. Offer process development services for Gene Therapy accounts by establishing and maintaining an active lab in Shanghai, including virus production and related analytical methods.
3. Draft and update continuously for all SOPs related to lab operations.
4. Train commercial team in specific virus production processes and applications.
5. Collaborate with commercial team to promote GE platform for virus manufacturing workflows.
6. Support sales activities in house and/or at the customer sites.
7. Keep close communication with global or local regulatory authorities regarding Gene Therapy guidance.
8. Present at scientific conference and/or in front of customers as needed.
9. Support publication of gene therapy application notes.
10. Understand marketing trends to support sales department and customers.
11. Able and willing to travel up to 20% of the time.
Role Summary/Purpose
The gene therapy process development scientist will be responsible for developing technical solutions for gene therapy manufacturing process, including mammalian cell culture, clarification and virus purification. Establish and maintain one active lab to deliver process development and technical trainings for both internal & external people. Collaborate with global CGT team and local commercial team to promote industrialized GTT solutions by GE GTT platforms.
Qualifications/Requirements
• Master degree with 5+ years industry experience or Ph.D. degree with 2+ years industry experience.
• Strong upstream technical background on mammalian culture, including culture medium screening & optimization, stirred-tank bioreactor expansion and the following clarification.
• Strong downstream technical background about virus purification by chromatography and filtration-based techniques.
• Has in-depth understanding for Quality control related to virus manufacturing flow.
• Familiar with related latest regulations, CFDA, FDA and EMEA.
• Has good knowledge about Good Manufacturing Practices (GMP).
• Experienced with DoE and other high throughput tools to implement QbD in process development.
• Good presentation and interpersonal skills, self-direction, people-oriented, proactive, good planning & execution skill, sense of responsibility, fast learner and team player.
• Good scientific writing and oral presentation skills.
• Fluent in English/Chinese (reading/speaking/writing).
Desired Characteristics
• Customer focused, commercially aware.
• Previous experience in an actual client-facing process development role.
• Excellent computer skills for document management.
• Enthusiastic, optimistic, passion self-motivated achiever.
• Reliable and thorough person who always delivers on promises and always promises realistically.
• Good organizational skills.
• Good team work with team members and local commercial team.
About Us
GE is the world's Digital Industrial Company, transforming industry with software-defined machines and solutions that are connected, responsive and predictive. Through our people, leadership development, services, technology and scale, GE delivers better outcomes for global customers by speaking the language of industry.
职能类别: 其他
公司介绍
GE医疗集团提供革新性的医疗技术和服务,以满足需求,使全世界更多的人能以更可负担的成本获得更好的医疗服务。GE专注于世界至关重要的问题,以优秀人才和领先技术致力于应对行业重大挑战。GE医疗集团在医学成像、软件和信息技术、患者监护和诊断、药物研发、生物制药技术、卓越运营解决方案等多个领域,助力专业医务人员为患者提供优质的医疗服务。
联系方式
- Email:Lei.zhu@ge.com