Senior Digital and Data Analytics Scientist, Cell Therapy
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Senior Digital and Data Analytics Scientist, Cell TherapyApply Now
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
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
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
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.
May be required to go on the manufacturing floor as required
regulatory submission and audit/PAI response as needed
Education and Experience 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.
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.”
LocationsUSA - MA - Lexington - BIO OPS
Time TypeFull time
Job ID R0030986