Process Validation Engineer
Process Validation Engineer
As a member of the Lentigen Technology Process Development team, you will have the exciting opportunity to advance the development and characterization of lentiviral vectors manufactured from clinical studies to commercial gene therapy products.
You will apply your process validation knowledge and development experience to identify design space and define process control ranges for viral vector production. You will draft characterization study protocols/reports and work with Development, Analytical, and pre-Clinical manufacturing Process Development team members to ensure a robust, scalable production process.
Your Statistical design/analysis software experience will allow you to utilize JMP Design of Experiment (DoE) and Statistics software to analyze previous data and perform studies to identify critical and non-critical process parameters as well as execute scale-down model qualifications. Your technical experience related to the development and/or manufacturing of biologics in a late-stage, commercial organization will enable you to perform risk assessments and FMEA, identifying TPP based critical and non-critical performance parameters.
Overall, your attention to detail and keen ability to reliably execute process validation activities in a cross-functional team will champion the continued development of Lentigen Technology’s new products and growing success.
- B.S.(+6 yrs), M.S. (+4 yrs), or Ph.D. (+2 yrs) in life sciences or chemical engineering and late stage biopharm industry product development experience
- In-depth knowledge of FDA, EMA, GMP and ICH regulatory requirements
- Demonstrated expertise in biologics process validation preferred
- Knowledgeable in Quality-by-Design and previous experience incorporating QbD principles into product development
- Experienced creating, reviewing, and updating FMEA risk assessment due to new processes or changes that potentially impact product
- Experienced in one, or both, of the following areas:
- Bioreactor based production of biologics incorporating batch, fed-batch, or perfusion modes
- Purification methods that include Harvest clarification, chromatography, Tangential flow filtration (TFF, UF/DF)
- Familiar with analytical methods used in the characterization of Lentiviral vectors (ELISA, Flow Cytometry, qPCR, ddPCR, Western-blot, HPLC, Nanoparticle analysis (NTA, FFF, TRPS, etc.)
- Superb documentation, organizational, and technical writing skills, capable of providing summaries and reports with little direct oversight
- Highly motivated, independent, detail-oriented team player. Good organization, initiative, and a collaborative attitude are essential
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