Gl Technical Steward Devices

Job Description Summary

Leads the Device & CP MS&T organization and manages the execution of the identified MS&T projects, activities, and processes to support manufacturing sites in their efforts to meet the Platform and Novartis TechOps business objectives, in accordance with legislation, internal rules and good practices. Management and development of associates in NOCC. Provides specialist knowledge, as Subject Matter Expert, for medical device and combination products processes or process technologies (e.g. Global Technical Steward for External Supply Operations (ESO) related topics.

 

Job Description

Key Responsibilities: General

• §  Build and lead a high performing organization, delivering a high level of service to the organization as required.
• §  Ensures that processes and activities in scope are standardized and implemented across the organization to maximize the value for the business in a cost-efficient way
• §  Ensure Technical support for IM device and combination products and projects.
• §  Collaborate with MS&T of platforms to drive application of standard work processes and best practices, specifically in validation, technical stewardship, launch & transfer, and product stewardship.
• §  Ensure that quality and compliance improvement and saving opportunities are applied globally.
• §  Drives a culture of excellence in manufacturing through standard setting and technical capability development and deployment, including implementation of process improvements.
• §  Drives a culture of excellence in manufacturing through standard setting and technical capability development and deployment.
• §  Co-Defines and supports the governance, to ensure that the right systems, processes, metrics, and key performance indicators are in place to implement and sustain the external device manufacturing processes in support of the operational strategy.
• §  Single Point of Contact for Sites & Platforms to discuss, assess and support implementation of activities for device topics.
• §  Other tasks as directed, and tasks based on a specific appointment.
• §  Other tasks determined by the annual objectives setting process and Key Performance Indicator.
• §  Implement and adhere to all the instructions and requirements of safety at work, environment protection and property protection.
• § Responsible for personal and professional development and for the development of associates.

Knowledge Management

• Provides the knowledge of specific medical device manufacturing process technologies, globally, including any pilot scale, scale up or down, Design of Experiments (DoE), as well as large scale manufacturing across multiple sites.
• Supports Site and ESO Technical Stewards/Managers in developing and/or aligning fundamental knowledge in the specific area of expertise. In collaboration with Technical Stewards/Managers ensures alignment and best practices in regular training and education programs provided to Process Experts and Operators.
• Assures that the necessary benchmark is done internally in Novartis and externally in the scientific and academic environment, in order to stimulate and to extend the knowledge, increasing the know-how of the associates and expanding it to the rest of the organization.

Subject Matter Expert (SME) for Platform

• Provides deep SME expertise globally across sites for processes and related equipment (e.g. galenical, chemical, biologics – upstream or downstream, etc) following product/process transfer or handover from launch to commercial production. Designs and controls optimization projects relevant to his/her specific expertise at cross- site level.
• Sets the standards for SME expertise to perform process characterization of the related pharmaceutical processes to increase robustness and sustainability in collaboration with development organizations and MS&T.
• Supports Technical Stewards / Managers and Product Stewards in trouble shooting by providing second level of specialist expertise as SME and by harmonizing and optimizing related technical processes across the units and sites globally.
• Author and implement GOPs for technology assigned.

Single Point of Contact (SPoC) for the technology

• Acts as the global SPoC for the interface with the Global MS&T network and with the technical development organization, for the corresponding global activities, to define and implement new technical standards for existing and new technologies and manufacturing processes.
• Collaborate with technical development, sites, CDMOs and the Global MS&T network to facilitate the transfer of technical knowledge.
• Responsible for setting the standards to perform technical feasibility trials related to process improvements and implementation of new manufacturing technologies.

Audit Support

• Maintains their work at a global level at inspection readiness level and provides the necessary support in any internal or external audit in addition to providing input to and review of regulatory documentation.
• Participates in / supports due diligence team, where applicable, for in-licensing projects.

Training

• Own the Training Curriculum for own Job Profile.
• Supports the development of training curriculum for Technical Stewards/Managers and assures alignment and best practices across sites. Provides the necessary training and support to new associates joining this position and other roles as needed.
• Provides the necessary training and education on related technologies to Technical Stewards, Global Product Stewards and whenever a specific expertise is required.
• Be a recognized scientific expert globally, internally and externally by reporting and presenting scientific / technical work at internal / external meetings or conferences and publishes in peer reviewed international scientific journals, including patents.

Key Performance Indicators (Indicate how performance for this role will be measured)

• The following KPIs will be aggregated and evaluated at Division level:
• Number of deviations
• Effective CAPAs
• Ppk – process capability
• Out of Specification (OoS) and Out of Expectation (OoE)
• Yield
• Customer Complaints
• Number of Recalls
• Stock outs / late delivery
• Success rate of internal audits and Health Authority inspections

Essential Requirements:Number of staff reportingDirect:                        Indirect: Financial responsibility(Budget, Cost, Sales, etc.)Operational Budget:Investment Budget:Impact on the organization

• Contribute to Platform manufacturing financial / business goals
• Significant support to achieve manufacturing strategy objectives by providing technology expertise on a global NTO scale.
• Significant impact to achieve success rates on internal and Health Authorities’ inspections through globally related technology management.
• Significant impact on ensuring competitive advantage in quality and costs by maintaining the relevant technology standards and introduction of new technologies through risk based management.

Ideal Background (State the preferred education and experience level)Education & Qualification(minimum/desirable):MSc. in Mechanical / Plastics Engineering or equivalent scientific degree. PhD or equivalent experience desirable.LanguagesFluent in English speaking / writing.Relevant Experiences

• Minimum 10 years experience in GMP manufacturing relevant to the specialist area of expertise
• Proven process understanding (Pharma, GMP, Regulatory aspects)

• Why Novartis: Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: https://www.novartis.com/about/strategy/people-and-culture
  You’ll receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. https://www.novartis.com/careers/benefits-rewards
  Commitment to Diversity and Inclusion:
  Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
  Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network.

 

Skills Desired

Change Management, Manufacturing Process Science, Manufacturing Production, Manufacturing Technologies, Process Control, Process Simulation, Quality Compliance, Technical Leadership, Waterfall Model