At Miltenyi Biotec, 3,000 employees worldwide develop pioneering solutions for biomedical science and the clinical application of cell therapies. Our multidisciplinary team combines excellence in research with the development of innovative products for the treatment of serious diseases.

Scientist, Process Development
(Analytical Methods, Molecular Biology)

Gaithersburg, MD

Tasks:

As a member of the Lentigen Technology Process Development Department, you will have the exciting opportunity to support the development, characterization, qualification, and tech transfer of processes to manufacture purified lentiviral vectors used for pre-clinical studies and clinical gene therapy products. The team’s work will contribute towards increased process understanding and product knowledge.

You will apply your Molecular Biology expertise to support quantitation and characterization of Lentiviral vectors using methods shown to be specific, sensitive, accurate, stable, robust, and reliably suitable for the specified purpose. You may support activities with QC for tech transfer of assays and will support activities related to assay qualification.

Your superb organizational and documentation skills will be instrumental in the tracking and communication of data and will ensure efficient progress towards achieving department and overall company objectives. You will provide summaries, development reports, and will present data and progress. In addition to your primary responsibilities, you will be responsible for providing training and support to additional team members as necessary.

Your attention to detail and keen ability to reliably develop and perform analytical assays and methods in a cross-functional team will champion the continued development of Lentigen Technology’s new products and growing success.

Requirements:

• Bachelor’s degree in the life sciences with 10 years, Master’s degree in the life sciences with 5 years, Ph.D. degree in the life sciences with 2 years of related experience, or equivalent combination of education and experience.
• Experience performing ddPCR and qPCR assays and methods.
• Other Techniques that are a plus: Particle Analysis, Cell Based Assays, Flow Cytometry, ELISA, SDS-PAGE, Western-blot, HPLC, and FFF-MALS.
• Experience with late stage product development, application of QbD principles, as well as statistical design of experiments with JMP or similar statistical analysis/DoE software.
• Experience developing, qualifying/validating, and troubleshooting analytical methods in GxP environment, supported with strong technical writing skills.
• Knowledge of applicable Regulatory guidance and standards (ICH, FDA, EMA, and USP).
• Incorporate use of controls and establish appropriate acceptance criteria to assays and test samples to ensure robust and consistent assay performance.
• Capable of independently planning projects, designing and executing experiments.
• Excellent organizational skills, necessary to multi-task in a fast-paced environment with changing priorities.
• Understanding of quality control laboratory operations in a commercial setting a plus.
• Highly proficient in the use of Microsoft Office products (Word, Excel, Powerpoint).
• Maintain a flexible work schedule as necessary to meet laboratory and client demands and timelines.
• Please note that this position may require vaccination against COVID-19, unless individual is entitled to reasonable accommodation under applicable law.

Physical Demands:

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 25 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.

Work Environment:

This job is performed in a temperature controlled facility without exposure to extreme hot or cold temperatures. Generally, this job is performed in a cleanroom setting and routinely uses standard medical and research equipment such as centrifuges, biosafety cabinets, microscopes, incubators, chromatography devices and columns, tangential-flow filtration devices and filters, peristaltic pumps and metering fill pumps, pipettes 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 lab coats, 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 Technology, Inc. is an EO Employer – M/F/Veteran/Disability/Sexual Orientation/Gender Identity.

Miltenyi Biotec, Inc. participates in E-Verify.