A hugely successful global biotechnology company is looking for Quality Control professionals across Analytical Chemistry and Data Management to join their rapidly expanding Quality Control group. This company has received recognition for their rare disease biotech products and are currently looking to increase headcount by 20% in the next 18 months. This role will play a pivotal part in the company's plans for growth by helping lead the QC department in multiple therapeutic areas including cell therapy, gene therapy, and genome engineering through Phases I, II, and III. This is a dream opportunity for anyone looking to make a difference in the lives of patients.
They have recently made several key hires within Analytical Chemistry and Data Management and are looking to speak with the best in the business to join the team and assist with the expansion plans. This is a very exciting and challenging opportunity that will offer someone a broad scope of responsibility. There is potential for significant growth and development.
The responsibilities will include:
- Review QC analytical SOPs, protocols, and reports
- QC analytical testing including HPLC, cell density, TOC, and pH
- Review in-process & release QC data across product platforms
- Adhere to GDPs guidelines
- Understands USP/EP requirements for product release
The ideal candidate will have the following skill set:
- ATMP testing experience
- BS/MS in Life Sciences or other relevant discipline
- Ability to problem solve, write and execute protocols, and control work instructions
- Background with statistics and proficiency with JMP, Prism, and SAS software
If you are interested in Quality Control roles, please don't hesitate to apply today!