Genscript Biotech Corporation is a global biotech company. The Company’s mission is to “Make the Human and Nature Healthier through Biotechnology”. Genscript Biotech Corporation is a leading life sciences research and application service and product provider that applies its proprietary technology to various fields from basic life sciences research to translational biomedical development, industrial synthetic products, and cell therapeutic solutions.
Leveraging in the Group’s proprietary gene synthesis and other technology and know-hows, the Group has established four major platforms including (i) a leading contracted research organization (“CRO”) platform to provide one-stop solutions to global research communities; (ii) a contract development and manufacturing organization (“CDMO”) platform; (iii) an industrial synthetic products platform; and (iv) an integrated global cell therapy platform. The CRO platform remains as the strong and stable revenue generating foundation for the entire corporate. The CDMO platform provides end-to-end biologics discovery and development services to pharmaceutical, biotech, government and academic customers worldwide. The industrial synthetic products platform develops products for food and feed processing and other industrial uses. The cell therapy platform provides cell therapy solutions to patients with refractory diseases including cancer and inflammatory diseases.
Backed by gene synthesis and editing technology, the Group has made significant progress in its synthetic biology research and application, which mainly materialized into its innovative chimeric antigen receptor (“CAR”) T-cell (“CAR-T”) therapy and industrial enzyme businesses. With a strong sales and marketing team and strong research and development capabilities, the Company maintains a stable and sustainable growth.
- Oversee the development, design, coordination, implementation, analysis, reporting, and maintenance of cross-functional projects.
- Review project proposals and project prioritization to keep projects aligned to corporate objectives.
- Ensures all of project compliance with all related rules and regulations.
- Collaborate with other departments (Manufacturing, Quality, Regulatory, Development, Finance, and IT) on project deliverable.
- Act as the point of contact for all safety-related communication, documentation, testing, inspection, reporting, and complaints resolving etc.
- Writes, reviews and/or revises Standard Operating Procedures related to Engineering systems and Processes.
- Author and execute Change Controls for GMP related Engineering/Facilities projects.
- Supports preparation of planning approval and capital approval documents.
- Responsible for the execution of safety stops, risk analyses, construction site safety, and correct management of regulatory issues.
- Responsible for facility handover, including turnover documentation to the user organization.
- Organize, modify, and keep updated the architectural, technical and design drawing for the entire organization in order to facilitate any regulatory requirements.
- Assist on various projects and performs additional duties as assigned to support the organization.
- Monitor all of the equipment, maintain building operations, and keep required record of each operation.
- Bachelor’s Degree in Engineering and 2 years experience in regulated industry and project management.
- Basic knowledge of CAD is preferred.
- Understanding of engineering and construction principles and safety requirements.
- Ability to work both independently and in a team environment.
- Ability to successfully, prioritize and manage multiple tasks simultaneously, integrate cross-functional issues and balance competing priorities effectively.
- Must be able to manage shifting priorities to meet critical deadlines in a fast paced and dynamic, growing environment.
- Ability to interact and communicate effectively at all levels of the organization and across different functions.
- Demonstrated strong PC, management, training, and presentation skills.
- Technical writing skills (policies, procedures, reference manuals).
- Excellent communication skills in both English and Chinese
GenScript USA Inc. is a proud equal opportunity/affirmative action employer committed to attracting, retaining, and maximizing the performance of a diverse and inclusive workforce. It is GenScript’s policy to ensure equal employment opportunity without discrimination or harassment based on race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity or expression, age, disability, national origin, marital or domestic/civil partnership status, genetic information, citizenship status, uniformed service member or veteran status, or any other characteristic protected by law.
GenScript USA Inc. maintains a drug-free workplace.