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

Job Title: Senior Scientist - Cell Process Development
Location: Gaithersburg, MD
Salary: $90,000

Tasks:

As a member the of the team, you will be responsible for technical leadership of a wide variety of projects to generate cellular therapeutic products. Additionally, you will design scope of work, generate any related documentation (as required), perform or supervise the studies, generate work product, coordinate testing, analyze data and results and create development reports. You will interact with clients prior to initiating a program (provide technical guidance) as well as throughout the project (provide updates and troubleshoot when needed). As a result of your ability to work with MSAT to facilitate leading the transfer of the process from Process Development into Manufacturing, you support the continued success of the company as a whole.

Among other responsibilities, you will:

• Act as the technical expert for the CliniMACS Prodigy processing platform, as well as for analytical methods 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.
• 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.
• Author Process Development technical reports, including data analysis and interpretation.
• 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 scientific coaching and mentoring to other staff members (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 scientific discipline preferred with 6 or more years of relevant experience; or MS in scientific discipline with 8 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, Virology, Molecular Biology, Cell Biology, etc.).
• Working experience in flow cytometry and /or PCR methods preferred.

You should know: Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.

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