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Manufacturing Sciences Principal Scientist
Manufacturing Sciences (MS) at Takeda Lessines Facility is a group that provides day to day support/training for manufacturing operations across the network, as well as creative and innovative solutions to ensure sustainable and enhanced process capabilities.
It develops process improvements and provides scientific & technical expertise to the facility manufacturing operations (purification and fill-finish activities for blood-derivative products). Focus areas are improving the process robustness, achieving higher capacity and process yields, , performing quality assessments and leading complex investigations. The Manufacturing Sciences group also works closely with Global Organization for the implementation and transfer of new processes and technologies into the regular manufacturing.
It is composed of the following dynamic teams: MS Laboratory, Digital & Data Science, Process Validation, and Process Sciences and Material Qualification (PS & MQ).
The Manufacturing Sciences Principal Scientist is a new position in the PS & MQ team, supporting the growth of the Manufacturing Sciences team and of the Lessines manufacturing site.
As Innovative Thinker and Scientific Driver with relevant experience in biologics drug development and industrialization, he will identify and drive the process development and improvement roadmap, in close collaboration with internal and external stakeholders.
As Senior Scientific Expert with strong expertise in protein biochemistry and bio-therapeutics manufacturing (upstream and downstream processes), he will be able to lead complex investigation, and will support the Manufacturing Science Specialists in their activities (complex investigations, quality assessment, process development and improvement projects).
As Principal Scientist, he will be accountable for the Process Knowledge Management of the PS & MQ activities, and for scientific consistency for Compliance activities (Audits, Regulatory Submissions).
Responsibilities as Manager:
Identify, support and drive innovative projects related to new or existing products, that will ensure process robustness and productivity:
-Closely collaborates with internal and external stakeholders to identify relevant ideas supported by strong business cases
-Leads cross-functional groups (also with other facilities) related to project implementation
-Uses QbD, DOE, pFMEA, Lean approaches, and implements new technologies (including PAT) where appropriate
-Support and coach Manufacturing Specialists in their projects
Lead and support complex CAPA investigations related to manufacturing operations:
-Uses DMAIC/Six Sigma approaches, and advanced statistical tools.
-Defines tasks/experiments to be performed, provides required documentation and ensures also that adequate corrective actions are implemented to address the identified root-cause(s).
-Favors communication, critical thinking, problem solving and team work across all manufacturing facilities.
-Ensures and defends adequate deployment, implementation and utilization of all quality systems as defined by Takeda Procedures within his organization. Ensures a thorough and timely handling of associated tasks.
-Ensures and defends the Compliance to cGMP’s, GDP’s, Licenses and Takeda Procedures by defining, implementing and maintaining appropriate SOP’s and training.
-Defends investigations in front of regulators during audits.
-Support and coach Manufacturing Specialists in their investigations
Lead the Process Knowledge Management Strategy of the PS & MQ activities:
-Ensures up to date Process FMEA (pFMEA) for new or existing processes
-Collaborates with Manufacturing Science team to establish relevant strategy and implementation of internal/external scientific training
-Ensures regular literature and industry process knowledge review and share it with the team and the site to favor fast and efficient learning curve
As Senior Expert in PS & MQ topics:
-Ensures appropriate documentation for regulatory filings, and defense during audits with health authorities (FDA, AFMPS, Japan, CBS,)
-Is involved in technology transfer and CMO related activities
-Support the PS & MQ team for scientific knowledge, including analytical methods, new process technologies, …
-Back-up the PS & MQ team members or lead when required
-PhD degree in Pharmaceutical Sciences, Bio-Engineering or BioChemistry with 8+ years of experience. Master's degree in same discipline with 12+ years of experience. Bachelor’s degree in same discipline with 14+ years of experience.
-Minimum 5 years of experience in Pharmaceuticals & Bio-therapeutics manufacturing, including biologics drug development and industrialization, with deep understanding of both protein biochemistry and structural biology.
-Strong background in QbD, DIDOV, DOE, pFMEA, Lean, Six Sigma and DMAIC approaches; Green/Black belt certification is an asset.
-Relevant experience in preparation of regulatory submission files and defending topics during FDA or cGMP audits.
-Excellent communication and ability to develop partnerships with relevant stakeholders.
-Effective project and resource management skills in matrix organization.
-Optimism, realism, innovation, critical thinking, problem solving, team collaboration.
-Independence and accountability.
-Living every day the Takeda Values (Integrity, Fairness, Honesty, Perseverance), and the Takeda Priorities (Patient, Trust, Reputation, Business).