Sr. Fellow opportunity in Cambridge, MA

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Matthew Masterson
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Sr. Fellow opportunity in Cambridge, MA

 As Required As a key member of the Advanced Therapy development group this individual will establish, manage, and own the T-cell proliferation process development (USP and DSP) and transfer for current and future AT (Advanced Therapy) projects. He/She will contribute to building development facilities and resources for T-cell proliferation process development. Additionally, contribute to interdisciplinary technical development work for AT projects in the larger development organization. An ability to interface with external partners to lead and monitor outsourcing activities and ensure deliverables according to Novartis standards, coach global team members, participate in global teams and contribute to overall TRD strategies and goals will be essential. As a leader of the AT process development activities he/she will actively participate in Oncology-DA, Development and MS&T teams, networks and/or platforms, and ensure quality, quantity and timelines in all assigned projects, networks and/or platforms. May have functional reporting responsibilities for approximately 1-5 people. Will be expected to proactively contribute to budget forecast, grant preparation and investment planning, and to advise development team members according to appropriate SOP?s, GLP, GMP, and other applicable Novartis guidelines. The candidate will act as a subject matter expert for cell therapies projects, interpret and communicate results, evaluate data, draw relevant conclusions and write reports. (S)he will contribute to optimization of scientific/technical activities and processes within the AT group. Contribute to risk analyses and/or peer review and process challenge meetings.

MS or equivalent in Cell Biology / Immunology / Bioprocessing or related sciences. English 3 years of relevant experience in process and medium development for processing (isolation, selection, activation, proliferation in suspension culture, process automation, separation and cryopreservation) for primary cells (T-cells, steam cells) for autologous and allogeneic cell production is strictly required. Strong fundamental knowledge of cell biology, immunology and cell culture process technology is required. Proven track record in utilization of special tools/equipment, lab automation tools and specialized facilities e.g., containment/sterile labs. Hands-on interest and experience with adherent and suspended primary cell cultivation, primary cell separation equipment and respective analytical methods is a must. A sound knowledge and practical experience in statistics (incl. DoE) is expected. GMP experience and a strong knowledge of relevant regulatory guidelines (FDA, EMEA, ICH) is required. Further requirements include team player with strong communication, established presentation and scientific/technical writing skills, good management skills with respect to planning, tracking, priority setting and adherence to project timelines. May require up to 25% travel.

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