MSAT Advanced Therapies Technology Professional

Beschrijving

Johnson and Johnson are recruiting for an MSAT Advanced Therapies Technology Deployment Professional in support of the Advanced Therapies Supply Chain preferably located in Leiden, Netherlands however additional locations such as Springhouse, PA will also be considered.

The Advanced Therapies Technology Deployment Professional will be responsible for supporting the technology strategy and leading the deployment of key technology projects and programmes with a key focus on data sciences and modelling across the manufacturing network. You will also be responsible for supporting the deployment of technologies with a focus on data sciences and modelling in partnership with the product partners through New Product Introduction and Life-Cycle Management activities to deliver value across our Advanced Therapies products, processes and plants, both internally and externally. This role will work closely with a team of MSAT data scientists and modelers to explore and deliver value focused data insights and process understanding to drive process and operational improvements.

In this role, we will be working as part of the MSAT Innovation & Technology Deployment organisation which works in a highly matrixed environment requiring a collaborative leadership approach. You will lead effective global and cross organizational teams to obtain desired results for all parties. We will partner with R&D, Quality, Site and Global Technical Functions, External Supply and MSAT Process Science and Modelling teams to ensure technology projects are successfully funded, planned, deployed, and sustained across the manufacturing network. The Advanced Therapies Technology Deployment Professional will have the opportunity to shape the identification and deployment of data science and modelling capabilities, working in close collaboration with other roles/functions, and must have strong interpersonal skills to influence other functions/levels outside of own group.

Solid understanding and experience in Process Analytical Technology (PAT), biopharmaceutical unit operations, process modelling and data analytics, advanced process control, artificial intelligence and the deployment of such technologies in a cGMP environment are desired. Knowledge of the key requirements for technology development and deployment in support of cell, gene and vaccine manufacturing processes is strongly desirable.

Have strong data sciences leadership and project management skills which you would like to apply to deliver new innovations? Have a passion for the application of data sciences and modelling and seeking to challenge the status quo? Do you want to have impact as part of an exciting and dynamic innovation organization? Do you have the drive to help deliver groundbreaking healthcare solutions to patients with significant need? If so, then you may be the person we are looking for!

Key Responsibilities:

• Lead cross-functional teams to support the deployment of technology projects
• Assess implementation requirements at manufacturing sites (Internal and External) to prepare implementation plan and budgetary requirements
• Support the preparation of the LRFP and associated business cases
• In partnership with R&D, MSAT teams and site/global collaborators ensure that data sciences and modelling projects and technology projects are successfully delivered and progressed to a sustainable state
• Ensure knowledge is successfully captured and transferred to technology receiving site
• Provide technical and compliance related input in support of risk assessments, change controls, validation documentation and regulatory submissions etc. serving as an MSAT Innovation Technology SME.
• Actively supports the management of an Advanced Therapies Innovation Technology Pipeline
• Development of Global Standard Technology Packages in support of technology replication
• Help build a culture of collaboration, agility, innovation, and competitiveness through constantly seeking business insight while also maintaining a focus on the external technology landscape
• Working with partners, identify and establish key data sciences and modelling capabilities in support of the Advanced Therapies Supply Chain
• Actively participate in cross-organizational and technology governance teams bringing an innovation approach for Advanced Therapies Supply Chain to the fore

Education:

• Masters in Science such as analytical chemistry, chemical engineering, data analytics/data sciences, statistics, biotechnology or related science or engineering discipline; B.S./M.S. with relevant industrial experience will also be considered.

Kwalificaties

Required:

Experience and Skills:

Proven experience in the application of data analytics and modeling for biopharmaceutical development and/or manufacturing processes is desirable

• Minimum of 4-6 years of experience working in pharmaceutical development and/or manufacturing operations environment
• Highly self-motivated and results focused, with track record of value delivery through technical innovation
• Experience with the development and deployment of technologies in a regulated environment with particular focused on data sciences and modelling applications
• Technical knowledge of biopharmaceutical manufacturing unit operations (DS & DP) and experience in the delivery of innovative solutions in a regulated environment
• Ability to synthesize business needs, manufacturing requirements and technology implementation considerations in support of technology deployment
• Advanced user of Excel and experience in the use of tools such as Tableau, SIMCA, JMP etc
• Understanding of the interfaces to OSI PI, Azure, SQL databases, SynTQ etc.
• Proven capability to successfully plan and implement technology projects in a biopharmaceutical manufacturing environment
• Hands-on experience in PAT, chemometrics, data science, artificial intelligence, multivariate data analysis etc.
• Possess broad knowledge across the entire Data Science lifecycle, including data engineering, statistics, and model governance and trust
• Demonstrated delivery of impactful data science applications
• Shown success at developing and maintaining collaborative relationships
• Excellent communication and presentation skills
• Ability to influence and lead peers, senior leaders and external partners

Preferred:

• Project management qualifications such as PMP or PRINCE2 certification
• FPX certification

Other:

• Fluent in written and spoken English
• 10% travel may be required, depending on project needs