Senior Scientist, Analytical Operations

The role:

The Senior Scientist will support Analytical Operations for Dispatch’s portfolio of product candidates, including therapeutic viruses, viral vectors, and autologous and in vivo CAR T cells. Reporting into the Associate Director, Analytical & Product Sciences (APS), this individual will be focused on creating and managing an effective operational network both externally and internally such that operational deliverables are met efficiently, effectively, and at high quality. Working under the guidance of the Associate Director, this individual is expected to engage with external partners (including supporting contract initiation), set up organizational systems that can track performance of external and internal testing, work with lab-based personnel to coordinate and perform routine testing, provide support to enable characterization, data generation, method development or validation as needed to facilitate  effective and productive operations for the entire APS team.

Key responsibilities:

• Coordinate execution for operational deliverables of external quality control testing including sample shipments between locations (e.g., CDMO to CTL or CDMO to Dispatch)
• Serve as the single point of contact between the Process Development (PD) team and APS team for PD studies and any other testing needs required from the APS team
• Manage internal routine testing processes including scheduling, verification, and reporting
• Create and/or manage systems for seamless data tracking for data collected at both QC/CTL sites and internally
• Develop and/or manage inventory systems to organize and track instrumentation as well as critical reagent and material usage at Dispatch (including commercial antibody reagents, in-house cell lines, reference standards, etc.)
• Assist with management and oversight of method validation and transfer activities, both internally and with external partners (e.g., CDMOs), as directed
• Assist with organization and coordination of MSAs/contracts
• Support budgeting activities as needed
• Effectively communicate operations status updates and any issues clearly to leadership at all levels, team members, and stake holders
• Maintain training and competency on selected internal analytical methods (qPCR, ddPCR, cell-based assays, biophysical techniques, etc.) and be ready to provide lab-testing support as needed
• Participate in seminars, journal clubs, and team meetings, and pursue ongoing scientific and professional development

Required experience & skills:

• Ph.D. with at least 5 years of related experience in an industry setting or Master’s Degree with at least 8 years of related experience in an industry setting or Bachelor’s Degree with at least 10 years of related experience in an industry setting
• CMC analytical experience within cell and gene therapy and/or large molecule antibody therapy
• Experience with method development, validation, and method transfers in accordance with ICH guidelines
• Lab-based experience developing methods and performing routine testing for at least three of the following analytical platforms: cell-based, Flow Cytometry, Analytical Microscopy, Capillary Electrophoresis, HPLC, AUC, TEM, qPCR, ddPCR, NGS, peptide mapping, residual impurity assays
• Experience scheduling testing for a team (e.g., lab-based scheduling of analysts, manufacturing-based scheduling of operators, or equivalent)
• Experience as a lab manager: ordering supplies for the lab, organizing reagents, ensuring supply of reagents is maintained
• Experience using electronic lab notebook (ELN) systems (Symyx, Benchling, etc.)
• Experience working with data analysis software such as GraphPad Prism, JMP, and Microsoft Excel
• Experience with shipping logistics (shipping samples domestically and internationally)
• Highly organized and proactive in setting up systems and tools for efficient data capture and data tracking (e.g., setting up or administering LIMS, inventory, or data-tracking tools)
• Experience working in a highly cross-functional matrix team
• Strong attention to detail and commitment to accurate, timely documentation of experimental data
• Experience collaborating with external partners (CDMOs and CTLs) as well as with internal cross-functional teams (e.g., overseeing method validation and transfer activities at external sites)
• Effective oral and written communication skills
• Familiarity with GMP/GLP laboratory practices or a regulated laboratory environment
• Ability to work collaboratively in a team-based laboratory environment
• Desire to learn, gain and grow new skills, be adaptable and apply new and existing knowledge in a fast-paced and dynamic environment

Preferred experience & skills:

• Technical understanding of analytical control strategy (release and characterization testing)
• Experience with authoring regulatory documents and source reports (IND, BLA, etc.)
• Experience as a Lead or Coordinator on matrix teams
• Experience working with project management software/tools (e.g., Smartsheet, Microsoft Project)
• Familiarity with data trending
• Familiarity with processes for review and execution of legal contracts and agreements (e.g., MSAs, CDAs) etc.)
• Familiarity with operational budget development, management, and tracking