QC Scientist

GenScript Biotech Corporation is a global biotechnology group with a presence across North America, Europe, the Greater China, and Asia Pacific. Founded in 2002, the company has established itself as a leading provider of gene synthesis technology and related services.

ProBio is a division of GenScript that specializes in providing end-to-end Contract Development and Manufacturing Organization (CDMO) services for cell and gene therapy, vaccine, and biologics development. Our team of experts provides proactive strategies, professional solutions, and efficient processes to accelerate drug development for our clients.

The QC Scientist will report to the Sr. QC Manager and be responsible for supporting the set-up, development, and maintenance of a GMP QC-Analytics Lab. This role will also involve supporting QC-Analytics initiatives, including equipment qualification, method development, method validation, and tech-transfer.

1. Support the development and maintenance of a GMP QC-Analytics Lab
2. Support QC-Analytics initiatives, including equipment qualification, method development, method validation, and tech-transfer
3. Perform a wide range of analytical tests, including UV-Spectrophotometry, qPCR, ELISA, HPLC, Endotoxin, MicroBCA, Electrophoresis, and DNA Sequencing/Analysis
4. Ensure compliance with cGMP and regulatory requirements
5. Develop and lead optimization initiatives to improve the QC department
6. Responsible for following cGMP in carrying out functions related to QC testing
7. Perform other duties as assigned based on business needs

1. Bachelor's degree with 3 years of relevant work experience
2. Experience working with Electrophoresis, UV-Spectrophotometry, HPLC, qPCR, ELISA, or DNA Sequencing/Analysis
3. Familiar with principles of Good Documentation Practices, Data Integrity, ALCOA+
4. Experience following Standard Operating Procedures or protocols
5. Ability to problem solve, and work independently and as part of a team
6. Experience with Microsoft Office tools
7. Experience with statistics, coding, programming, troubleshooting, and/or data management software is a plus
8. Strong interpersonal, verbal, and written communication skills
9. Experience working with QC intermediate and release testing
10. Experience working with HPLC, qPCR, ELISA, and/or DNA Sequencing/Analysis
11. Experience with Quality Management Systems and Investigations
12. Experience with governing regulatory bodies, such as FDA, ICH, and EU Annex 1
13. Experience with documentation, by way of authoring, reviewing, and/or approving GMP documents
14. Experience with Laboratory Information Management Systems (LIMS), or relevant data management software
15. Experience as a trainer is a plus

GenScript USA Inc./ProBio Inc. is an equal opportunity/affirmative action employer committed to attracting, retaining, and maximizing the performance of a diverse and inclusive workforce. We are committed to ensuring equal employment opportunity without discrimination or harassment based on race, color, religion, sex, 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.