Scientist, Cell Process Development *PC

Pay Competitive

Location Gaithersburg/Maryland

Employment type

Full-Time

Req#: SCIEN
002988

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, Cell Process DevelopmentGaithersburg, MD

Your Tasks:

As the Scientist, Cell Process Development, you will be responsible for designing scope of work for analytical transfer used in the development of cell therapy product and generating any related documentation. You will be expected to interact with the client prior to initiating a program and (providing technical guidance) as well as throughout the project (providing updates and troubleshooting when needed).

Additionally, you will be expected to work with different teams to facilitate leading the transfer of the process from Process Development into Manufacturing.

Essential Duties and Responsibilities:

• Perform or supervise the analytical studies, generate work product, coordinate testing, analyze data, provide interpretation of results and create development reports, including cell-based and molecular biology assays.
• Liaise closely with client representatives to ensure their expectations are met or exceeded. This should include input into technical design of studies and ongoing scientific support throughout these projects / programs.
• Facilitate leading the transfer of the process from Process Development into Manufacturing.
• Support Business Development and Project Management to generate proposals, statements of work, timelines and ensure timely initiation and completion of all studies.
• Generate Process Development protocols to serve as guidance for study execution as well as means for real-time documentation.
• Participate and/or lead process and analytical method transfer and/or Process qualification activities.
• Work closely with Quality Control and Manufacturing Science and Technology groups to translate development projects to GMP compliance.
• Participate in critical event / lab investigations / troubleshooting within Process Development and liaise with Project Management to ensure the significance of events is actively communicated to clients.
• Lead by example, offer training and scientific support for ongoing projects.
• Provide technical advice and support for client and regulatory interactions (audits, meetings, teleconferences and inspections).
• Monitor industry trends to ensure that relevant new technologies can be assessed and evaluated. Review and recommend potential technical developments to supervisor and to senior management.
• Process development material purchasing and management.

Requirements:

• Ph.D. in Cell Biology and Immunology preferred with 4 or more years of relevant experience; or MS in Cell Biology and Immunology with 6 or more years relevant experience; or equivalent combination of education and experience.
• Relevant working knowledge and hands-on experience in area executing and overseeing technical projects and/or related studies (i.e. Immunology, Cell Biology, etc.). Working experience in flow cytometry is required. Hands-on experience with PCR methods is preferred.
• 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 20 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:

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 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…