MSAT (Manufacturing Science and Technology) Engineer
MSAT (Manufacturing Science and Technology) Engineer
Description
About GenScript
GenScript Biotech is the world leader in biotechnology reagent service industry, as well as an open platform for pre-clinical drugs discovery and pharmaceutical development, driven by innovative technologies. As a public company (HK Stock: 01548), our mission is to make human and nature healthier through biotechnology. Established in 2002, the company headquarter is located in Nanjing, China, with production and operation center in both Nanjing and New Jersey, United States. There are also branches in EU, a R&D center in Ireland and a logistics center in Netherland, and branch in Japan. With these facilities, we have been serving more than 100 countries and 200,000+ customers around the world for more than 16 years. For more details, please refer to our website www.genscript.com.
Position: MSAT (Manufacturing Science and Technology) Engineer
Location: Piscataway, NJ
Report to: Head of GMP Site
Role Description:
We are looking for a MSAT engineer to provide process development and engineering support for technology transfers, process validations and GMP manufacturing. Additionally, draft and review protocols, production procedures, and process development reports, and provide technical assessment and approval for engineering and process changes as well as documentation pertaining to process development, characterization, and validation to meet regulatory requirements. This role will focus on aspects of ensuring a robust, scalable and efficient manufacturing processes to produce late-phase human clinical trial and commercial gene transfer biological products.
Key Responsibilities:
- Lead process-related deviations and provide technical support to manufacturing
- Investigate, identify root-cause for critical deviations and determine CAPA for manufacturing
- Write product impact assessments to support deviations
- Write and review technical documentation (batch records, SOPs, protocols, and reports)
- Ensure successful manufacturing production runs by assessing risk, setting preventative measures in place, investigating, and troubleshooting equipment and process issues
- Design and execute process validation studies to develop a thorough understanding of operating and performance parameters
- Perform hands-on activities that support process development and process characterization, ranging from drafting procedures to execution of laboratory studies
- Support cross-functional technology transfer teams for cGMP
- Collaborate with another site or clients to ensure success of scale up/process transfer
- Execute cell culture or downstream laboratory work while maintaining good laboratory practice
Requirements
- Bachelor or advanced degree in Biochemical, Biomedical,Chemical Engineering or a related scientific discipline such as Chemistry or Biology
- Looking for 5+ years’ relevant experience or Master’s degree with 3+ years’ experience
- cGMP pharmaceutical MSAT or technical services, technology transfer or process development experience preferred
- Strong interpersonal and communications skills; written and oral
- Ability to function in a fast-paced dynamic team environment and balance characterization multiple projects
- Knowledge of cell and gene therapy vector production is desirable
- Understands and employs principles and concepts of Lean Six Sigma to improve process capability is a plus
- Knowledge of data management tools and statistical process controls is preferred
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.