As a member of the Lentigen Technology Process Development team, you will have the exciting opportunity to serve as a CMC technical lead contributing towards the development and characterization of Lentiviral vectors, from clinical studies to commercial gene therapy products.
- Work in a matrix environment between Development, Analytical, Manufacturing, Quality, and CMC Project management to perform process risk assessments and design and execute characterization studies
- Identify Design space and define Process control ranges for viral vector production
- Draft Characterization study protocols/reports and work with Development, Analytical, and pre-Clinical manufacturing team members to ensure a robust, scalable production process and control strategy
- Utilize JMP Statistics software for Design of Experiment (DoE) and data analysis to identify critical and non-critical process parameters as well as support the design and execution of scale-down model qualifications
- Technical writing in support of CMC documentation
- The ideal candidate will have a B.S. or more advanced degree in life sciences or chemical engineering, with a minimum of 5 years experience in late stage biologics development
- Knowledge of FDA, EMA, GMP, and ICH regulatory requirements
- Demonstrated expertise in biologics process characterization and validation preferred
- Knowledgeable in Quality-by-Design (QbD) and previous experience incorporating QbD principles
- Experienced creating and updating risk assessments 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 clarification, chromatography, and Tangential flow filtration
- Familiar with analytical methods used in the characterization of Lentiviral vectors (ELISA, Flow Cytometry, qPCR, ddPCR, Western-blot, HPLC, Nanoparticle analysis)
- Strong documentation, organizational, and technical writing skills, capable of providing summaries and reports with little direct oversight
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to walk; use hands to finger, handle, or feel; reach with hands and arms, talk, and hear. The employee is required to stand; climb or balance and stoop, kneel, crouch. The employee must occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, color vision, peripheral vision, depth perception and ability to adjust focus. Must have ability to handle more than one task at a time and must work at a rapid pace while maintaining attention to detail.
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. This job is performed in a temperature controlled facility without exposure to extreme hot or cold temperatures. Generally, this job is performed in a sanitized laboratory setting and routinely uses standard medical and research equipment such as biosafety cabinets, CO2 incubators, centrifuges, pumps, bioreactors, microscopes, and computers. While performing the duties of this job, the employee is frequently exposed to blood, viruses, bacteria, body fluids and other tissues. Employees entering and leaving the laboratory must wear appropriate clothing and protective equipment such as masks, glasses and gloves. The noise level in the work environment is usually moderate.
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, Inc. is an EO Employer – M/F/Veteran/Disability/Sexual Orientation/Gender Identity