Senior Process Development Associate
Senior Process Development Associate
As a member of the Lentigen Technology Process Development team, you will have the exciting opportunity to support the development, characterization, and tech transfer of processes to manufacture purified Lentiviral vectors used for pre-clinical and clinical gene therapy products. You will apply your cell culture experience to support production, and characterization, of Lentiviral vectors using adherent and suspension based production platforms. Ideally, you will be able to carry out all aspects of upstream vector production with the goal in mind that every effort is aimed at developing and qualifying processes required for clinical gene therapy products. In addition to your primary responsibilities, you will order necessary supplies, maintain laboratory equipment and space, prepare media and buffers, and train team members as needed. Your superb organizational and documentation skills will be instrumental in the tracking and communication of data and will ensure efficient progress towards achieving team objectives. Overall, your attention to detail and keen ability to reliably produce Lentiviral vectors in a cross-functional team will champion the continued development of Lentigen Technology’s new products and growing success.
- Bachelors degree in the life sciences with a minimum 5 years of related experience; or equivalent combination of education and experience.
- Previous biotech industry experience is preferred, specifically in the fields of gene therapy and virology
- Experienced at passaging and producing in adherent cell culture systems (i.e. Cellstacks, Cell Factories, Dishes/Flasks)
- Experienced at passaging and producing in suspension cell culture systems (i.e. Stirred-tank bioreactors, Wave bioreactors, Shaker flasks)
- Strong experience utilizing single-use technologies in the production or purification of biologics
- Working knowledge of common purification techniques (i.e. Filtration, UF/DF, Chromatography, etc.). Experience is a plus.
- Previous experience performing assays and methods commonly used for viral vector quantitation and characterization (ELISA, Flow Cytometry, qPCR, SDS-PAGE, Western-blot, HPLC, Particle analysis, Host cell protein detection, Total Protein and Nucleic acid quantitation methods, etc.)
- Knowledge of cGMPs
- Experience in process validation and technical writing.
- Superb documentation and organizational skills, capable of providing summaries and generating development reports to support technical transfer to Manufacturing as well as process qualification
- Experience with late stage product development, application of QbD principles, as well as statistical design of experiments with JMP software is a plus.
- Highly proficient in the use of Microsoft Office products
- Weekend and holiday work may be required to maintain cell culture vessels or set up assays.
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