Senior Digital and Data Analytics Scientist, Cell Therapy at Takeda in Lexington, MA

Job Description

The Senior Digital and Data Analyst Scientist will be responsible for the implementation, deployment, and use of GMP electronic compliant systems for the new Commercial Cell Therapy operations facility. You will provide your leadership, management, and support of start-up operations and establish the design of digital and data analytics systems and procedures, including support for electronic batch record creation. As a specialized individual you may act as the system operational owner of GMP applications for manufacturing for example, process data analytics tools. You will be expected to utilize platforms for real time monitoring, predictive and statistical analytics for report-outs, resolutions, continuous improvement, and CPV in support of manufacturing operations.

Key support services, deliverables, and capabilities within this function include:

• Lead or participate in workshops for operational technology tools and vendor selection
• Be the technical lead for system implementations and participate in the definition of integration strategies for GMP applications
• Coordinate execution of project tasks with other members of the manufacturing systems team
• Coordinate SOP creation and training activities as part of Business Continuity management in preparation for facility start-up and new product introduction
• In collaboration with other teams oversee design, implementation, validation, change management and maintenance of digital and data analytics systems and procedures (e.g. SIMCA)
• Have specific subject matter expertise in process analytics and working knowledge of distributed control systems e.g. Pl historian, Power BI, Statistica, LIMS, JMP, ED, and other multivariate process analytical and control tools
• Have expertise to identify potential improvement projects, address deviations, and CAPA’s utilizing advanced analytics and process knowledge (PAT, QBD, etc) and take ownership of the user experience of deployable systems
• Act as a data steward for Cell Therapy site Operations
• May Supervise work of contract and junior personnel
• Drive the organization towards a culture of safety, innovation, collaboration, best practice, accountability, and efficiency
• Train on relevant industry standards for systems and stay current on industry best practices by attending in house and off-site seminars and conferences

Other Responsibilities:

40%

• A key part of this role will be establishing, leading and implementation of real-time multivariate and predictive analytics platforms in support of manufacturing.This requires close interface with MST Process Owners, Site Digital and Data groups and clear understanding of processes
• Have expertise in multivariate modeling methods, including PCA/PLS, OPLS, Discriminant analysis, etc and work with subject matter expert to collect and process data for use in creating models, utilizing a variety of automated tools
• Develop analytics for trending, root cause analysis, resolution, and continuous improvement for deviation investigation and CAPA’s
• In conjunction with MST process engineers and others provide clear routine assessment and communications on process status, predictive analysis and support on resolutions and improvements

30%

• Provide analysis of data aimed at process knowledge development with a focus on proactive process improvements and resolution of investigations
• Provide technical support of ongoing routine event response, containment, and investigation support of GMP operations
• Implement continuous improvements in alignment with operations program needs and site & global initiatives
• Create training and communications for business users to enable visibility and effective use of

20%

• Process Data Storage and Communication by developing and maintaining a standardized system for storing and communicating process data. This will include all key process indicators that will be routinely monitoring by MST floor support and communicated on an exception basis
• communicate to external customers (Manufacturing) and cross functional partners (QA and MST).
• Ensuring uptime and working with Automation and IT to troubleshoot any server, connection, or configuration issues.

10%

• May be required to go on the manufacturing floor as required
• regulatory submission and audit/PAI response as needed

Education and Experience Requirements:

Minimum Requirements

• Bachelor’s Degree in a technical discipline with 8+ years, Master’s Degree with 6+ years, or PhD with 2+ years of experience
• Implementing or managing GMP systems for manufacturing operations such as MES (Manufacturing Execution Systems), applicable process automation, advanced process monitoring or process data historians, technical support, or process/facility design experience for biologics
• Working in a manufacturing facility and GxP experience
• Experience in the practical use of statistics for operations, including predictive analytics, data mining, multivariate analysis
• Experience with some of the following:
• database design, process historian/data collection systems and data analysis/reporting applications such as SIMCA, Pl Historian, Pl Process Book, Excel, JMP, Power B and Statistica, Discoverant, OPC DA, and UA technologies
• Experience with SOLC and CSV methodology and compliance standards for project deliverables
• Design or operational experience in GMP biological processes
• Previous project management experience implementing similar systems/programs at other biotech or biopharmaceutical companies

Occasionally, may be necessary to travel to: Takeda locations to attend business meetings (less than 10% time) and professional trainings or industry conferences. Periodic weekend call-in coverage. May require on-site assistance if warranted.

Preferred Requirements

• Gene/Cell Therapy experience
• Ability to write maintainable code in programming languages
• Technical experience/knowledge of major unit operations associated with biologics manufacturing such as cell culture

Key Skills, Abilities, and Competencies

• As an active participant on multiple cross-functional teams, the candidate must demonstrate excellent written and verbal communication skills.
• Effectively communicate issues cross-functionally and resolve them in a timely manner.
• Candidate must also provide guidance and leadership for junior team members for strong working relationship with key business partners and stakeholders and across all cross functional groups.
• Ability to deliver high level training to users of business operations systems to a wide range of users in the manufacturing organization
• Ability to interact well in multifunctional teams and with personnel at all levels in the organization, including Cell Therapy Translational Engine, IT, QA, Manufacturing, Engineering, Process Technical Support and Validation
• Capable of leading productive meetings to request, compile and document user requirements
• Adaptable to changing priorities and performing at a high level in a fast-paced environment
• Experience with systems validation execution and related documentation
• Strong written and verbal communication skills, particularly presentations to a wide audience of multiple functions and various technical levels of expertise
• Demonstrate high-level of professional and business judgment when communicating with cross-functional teams and with external consultants
• Knowledge of GMP manufacturing processes and good understanding of dependencies between materials, process conditions and in process and final product test results
• Aptitude/interest in systems for manufacturing operation management, and willingness to learn and implement new technologies, standards, and best practices
• Understanding of biopharmaceutical batch manufacturing, material flow, unit operations and process parameters
• Ability to apply industry regulations and applicable technology standards to decision making process
• In coordination with team leadership, prioritize tasks to ensure timely completion of activities
• Participate in problem resolution meetings/teams effectively
• Ability to shift priorities to meet required deadlines
• Strong problem-solving skills and attention to detail

“This job posting exclude Colorado applicants.”