How you will contribute:

• You will be partnering with data scientists to develop an infrastructure and processes for the contextualization, organization, visualization, and storage of the generated data, so as to enable autonomous and intelligent process development. Identify and convert physical activities in development and lifecycle to digital platforms, ie. Shipping studies, mechanical testings, etc. Transformation of manual activities into digital. i.e. Complaint handling.
• You will have deep experience processing large data sets and applying advanced methods to visualize and extract value from them. You will have experience with developing workflows for data collection using a wide range of automation tools, from traditional platforms to the use and development of complex software solutions. You will have knowledge of multiple process analytical technologies (PAT), Pharma 4.0 digital maturity models and systems, and testing and building simulation models. You will be striving to improve our workflows to facilitate and accelerate process development, optimization, and understanding.
• You will be recognized as a technical resource/expert within DPDD and across Pharmaceutical Sciences and utilize technical expertise to contribute across multiple projects and drive technical/scientific strategy. You will be collaborating closely with product development groups, digital and manufacturing based on pipeline needs and current trends in research. You will be responsible for maintaining and growing the department's strategic relationships with our outsourcing partners, academic collaborators, and pre-competitive consortia, as well as directing and managing outsourcing across a product platform, as appropriate.
• Individual contributor responsible for developing automation solutions, simulations, and modeling to accelerate process design, development, optimization, and characterization, and to mitigate risk in manufacturing.
• Develop project or technical strategy and leverage technical skill(s) as a resource/expert within the department.
• Develop and manage strategies for projects and execute complex experimental protocols.
• Initiate complex projects with extraordinary technical challenges and apply technical risk assessment skills.
• Own a discipline/technical skill in its entirety and continue to develop expertise in other technical skills.
• Contribute to develop and achieve direction of departmental activities, management of resources, time, personnel and financial resources. Maintain ownership of overall vision of scientific platform.
• Communicate and coordinate implementation of technology/scientific improvement to senior management, across therapeutic and scientific areas.
• Conduct analysis of technical and conceptual risk, identify trends and defines and process or scientific strategies.
• Incorporate novel automation technologies and industry trends as a key aspect of scientific strategy development.
• Maintain complete technical responsibility for program(s)/initiative(s) within the department.
• Ensure project management of all plans and projects within your responsibilities, linking all scientific efforts to company, program and functional goals.
• Lead small working groups to address knowledge gaps in programs linking departmental strategy to strategies of other relevant functions.
• Identify topics for initiatives and lead local/global and cross-functional initiatives on behalf of senior staff.
• Recognized as a technical leader/resource by the group and fosters development of technology skills within department and among junior staff.
• Contribute to departmental and divisional strategy around scientific improvement and new capabilities.
• Make proposals regarding sourcing/consultancy strategy.
• Communicate with senior management of other functions on implementation of infrastructure, technology, work processes, or business processes.
• Author relevant sections of regulatory documents, validation plans, reports and peer reviewed manuscripts.
• Proactively identify vendors and builds relationships to gain access to technologies as needed to deliver on pipeline goals.
• Manage key vendor relationships across multiple projects, and proactively affect resolution of issues arising at vendors.
• Represent Takeda and be an active member on pre-competitive collaborations with academic and industrial partners.
• May require approximately 10% travel.

Minimum Requirements/Qualifications:

• PhD in chemistry, biology, pharmacy, engineering or related pharmaceutical science; 0+ years relevant industry experience
• Masters degree in chemistry, biology, pharmacy, engineering or related pharmaceutical science; 6+ years relevant industry experience
• Bachelors degree in chemistry, biology, pharmacy, engineering or related pharmaceutical science and 8+ years relevant industry experience
• Extensive experience in the use of mathematical, both statistical and first principle, models as well as advanced process control systems.
• Extensive experience in building reaction kinetic models as well as process models preferred.
• Extensive experience in a range of Automation Technologies and Platforms as well as Pharma 4.0 digital maturity models and systems.
• Experience managing staff preferred.
• Sound knowledge of current Good Manufacturing Practices (cGMP).
• Experience in working in a multi-disciplinary team environment.
• Significant technical and strategic leadership and accomplishments
• Previous experience contributing to regulatory filings, preferably experience will late-stage filings.
• Proven scientific track record through presentations at scientific conferences and publication of peer-reviewed manuscripts.

What Takeda can offer you:

• Comprehensive Healthcare: Medical, Dental, and Vision
• Financial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan
• Health & Wellness programs including onsite flu shots and health screenings
• Generous time off for vacation and the option to purchase additional vacation days
• Community Outreach Programs and company match of charitable contributions
• Family Planning Support
• Flexible Work Paths
• Tuition reimbursement

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