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The Sr. Manager Process Engineering of Manufacturing Technologies and Sciences (MTS), reports to the Director-MTS, and is responsible for providing leadership, technical management, and professional development for the MTS Engineering team as well as collaborating between MTS Process Specialists Team, MTS management, Project Management, Process Development, Purchasing, Validation, Quality, Safety & Manufacturing teams. A major responsibility for the Sr. Manager is to provide technical support and strategic direction to internal stakeholders and external clients, providing guidance to technical writing and decision making in the execution of the specific client project deliverables, all performed in a timely manner. The Sr. Managers’ actions support overseeing of Process Engineering into PCI manufacturing, plant floor operations (formulation/fill/finish/lyophilization), and development of manufacturing documentation supporting new product introduction.
Job Responsibility:
Lead and manage the Process Engineering team within MTS, including hiring, training, and development
Manage team to support the planning and execution of tech transfer/new product introduction projects
Support complex/challenging processes with unique equipment, componentry, processing requirements
Manage team to Identify and Implement new technologies and methodologies within the MTS function
Design/Review/Approve engineering drawings
Develop and execute comprehensive technical transfer plans
Support process characterization studies, process validation activities, and risk assessments
Support resolution of complex manufacturing issues and provide technical support of critical process-related deviations
Manage/Support the technology transfer of processes from internal and external development groups
Provide technical leadership and guidance to both internal and external requirements for defining scope, planning, scheduling resources and overseeing the MTS project support activities
Provide technical perspective during internal and external audits, regulatory inspections and due diligence
Facilitate tactical support of ongoing plant operations and strategic implementation of engineering projects
Interface directly with all clients to ensure highest level of customer satisfaction is achieved
Demonstrate and promote continuous improvement in efficiency, quality, and safety
Remain current with biopharmaceutical industry best practices, technologies and developments
Build and lead a team of process engineering experts
Key technical leadership for clinical/commercial stage programs including technology transfer, validation, process design, and manufacturing support
Develop and implement strategies for continuous improvement across manufacturing processes
Interpret manufacturing process data, identify trends, troubleshoot problems, and drive data-driven decision-making
Coordinate the preparation, review, and approval of technical documentation
Requirements:
Minimum of 14 years of technical experience within Life Sciences (Biopharmaceutical/Biotechnology), Medical Device or Aseptic Manufacturing Organization with GMP industry experience
BS/MS in chemical, mechanical, pharmaceutical engineering or relevant work experience
Strong hands-on experience in either Process Engineering/Sciences, Manufacturing Operations, or Technical Project Management
Prior people managing experience, supervisory experience at a minimum
Experience leading and driving large projects and initiatives to completion
Nice to have:
Prior lyophilization experience
Experience preferably in a biopharmaceutical or medical device manufacturing organization with familiarity with aseptic manufacturing