General Electric Process Development Scientist – Gene Therapy Technique in Shanghai, China

Role Summary:

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.

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.

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.

Locations: China; ShangHai; Shanghai