Lentigen - Process Development Associate (Downstream)
Process Development Associate (Downstream)
As a member of the Lentigen Technology Process Development team, you will have the exciting opportunity to support the development and tech transfer of processes to manufacture purified lentiviral vectors used for pre-clinical and clinical products. You will apply your purification experience by utilizing various filtration and chromatography methods to carry out experiments and develop processes to support the manufacturing of Lentiviral vector products. Expertise in downstream technologies and analytical methods will enable you to support scalable production model development, and your extensive experience with AKTA chromatography systems and method writing in Unisorn software will be essential to assist in the development and technical transfer of methods and processes required to be used in a GMP manufacturing facility. Overall, your attention to detail and keen ability to reliably perform downstream processes in a cross-functional team will champion the continued development of Lentigen Technology’s new products and growing success.
- Bachelors (+7 years), Masters (+5 years), or Ph.D. (+2 years) degree in life sciences or biochemical engineering with indicated experience; or equivalent combination of education and experience
- Execute viral particle purification methods that include cell culture supernatant harvest and clarification, column/membrane chromatography, filtration technologies (UF/DF, Dead-end, etc.)
- Pack chromatography columns, run column performance tests, and qualify chromatography processes
- Troubleshooting equipment (AKTA Systems) and process related issues
- In addition to AKTA based FPLC, perform analytical chromatography to characterize purified viral vector and identify critical quality attributes in support of process characterization
- Perform assays in support of Lentiviral vector characterization (ELISA, qPCR, ddPCR, Western-blot, Particle analysis, Flow Cytometry etc.)
- Superb documentation and organizational skills, often providing summaries and generating development reports
- Highly proficient in the use of Microsoft Office products
- Familiarity with techniques for adherent and suspension cell culture in flasks and cell factories as well as bioreactors is a plus
- Experience with late stage product development and software based statistical analysis (JMP) as well as design of experiments is a plus
- Experience with principles of Quality by Design (QbD) is a plus
Lentigen Technology Inc., a Miltenyi Biotec company, is transforming and progressing. Our culture is one of bold scientific innovation. Join a fresh and collaborative working environment that encourages contribution, innovation, and growth.
At Lentigen, we support the development and commercialization of novel treatments for human disease through the utilization of lentiviral vectors. We hold this widely recognized and clinically relevant method for delivering genetic materials into cells in order to modulate their function as a core strength of our company. We are scientists, engineers, physicians, support specialists, and more – all dedicated to improving scientific understanding and impacting human lives. At our Gaithersburg campus we strive to find solutions to both the technical and conceptual barriers to the implementation of gene therapy approaches for the treatment of human disease.
Lentigen Technology Inc. is an EO Employer – M/F/Veteran/Disability/Sexual Orientation/Gender Identity