Senior Manager, Process Monitoring

How you’ll make an impact:

Develop and implement the process monitoring strategy for 2Seventy bio’s portfolio of cell therapies to fuel our ask/answer engine.  From supporting complex investigations to driving data-driven decisions on process and product improvements, you’ll work across the Technical Development and Operations, Clinical, and Research functions in this critical role.

About the team:

In 2Seventy bio’s Data & Analytics department, we see the power of data to enable scientific innovation throughout the organization to bring life-extending cell therapies that give back time to patients and their families.  Our mission is to

• Honor our patients by applying cutting-edge data analytics & innovation and driving digital transformation, and
  • Make data FAIR (findable, accessible, interoperable, reusable) across research, clinical, and manufacturing.

We fuel 2Seventy bio’s ask/answer engine and bring data-driven decision making from early discovery through commercialization.

How you’ll spend your time:

The focus of the Process Monitoring Lead role is to develop and execute the process monitoring strategy for 2Seventy bio’s portfolio of T cell-based cancer therapies.  This role is a unique combination of process and data science and will be a key contributor to the Process Data Systems & Statistics group’s mission to provide advanced data analysis and insights to our stakeholders in Technical Development & Operations and the CMC and Program Teams.  Responsibilities include:

• Building the technical infrastructure and business processes for phase-appropriate process monitoring across the drug development lifecycle
• Developing a standardized playbook for managing process data, including template process definitions, nomenclature/metadata, and data visualizations and dashboards
• Partnering across the Data & Analytics department to integrate manufacturing, clinical, and translational data to enhance process understanding and inform decisions
• Collaborating with process development and manufacturing on complex deviation investigations and identifying opportunities for process improvements
• Supporting the development of dashboards and automated reporting capabilities for manufacturing process capability assessment
• Authoring and/or reviewing technical documents such as process monitoring plans, SOPs, change controls, investigations, and CAPA

We seek candidates with a strong technical background and experience in late-stage and/or commercial biopharma manufacturing or development.  A proven ability to successfully work both independently and collaboratively to achieve aggressive timelines is required.  The successful applicant will play an important role in delivering pioneering cell therapies that transform the lives of cancer patients.

Who you are and what you’ve accomplished:

• BS/MS degree in an engineering, or scientific field with relevant experience
• 8+/6+ years of work experience in a relevant biotechnology role (e.g. CPV lead, MSAT, Manufacturing, Process Development);
• Knowledge of SOPs, cGMPs and experience operating in a GMP manufacturing or development environment;
• Demonstrated problem solving ability and analytical thinking;
• Must have excellent attention to detail, project and time management skills, the ability to manage multiple priorities, and to adhere to scheduled timelines while maintaining flexibility to adapt to an evolving project portfolio;
• Ability to communicate above and below level in a way that fosters relationship building, including cross-functional teams, and external relationships with vendors
• Successfully worked in a collaborative team environment where results are achieved through influence and incorporating multiple points of view
• Experience in statistical analysis is highly desired;
• Experience with the use of software packages for data analysis (R, JMP, Minitab, etc) and process information management (Discoverant, Skyland, etc)
• Familiarity with data visualization/dashboarding tools (e.g., Power BI, R/shiny, Spotfire) preferred
• A “do-what-it-takes” attitude to meeting challenges;
• Embraces and models our core values—re:think, have:heart, better:2gether, time:is now