395396BR
May 08, 2024
Slovenia
About the Role
As part of the Biocampus project in Menges, this position will be initially responsible for developing and managing production and business processes within the entire Clinical Manufacturing Drug Product unit value chain. They will implement the plans for the process and production unit, develop the field of expertise and ensure competitiveness, quality, safety and supply for internal customers in accordance with legislation, internal regulations, good practices and business objectives.
The Director Clinical Manufacturing Drug Product, will then lead the site’s Drug Product Process department, and ensure that equipment, infrastructure and manufacturing areas are fully operational, meet regulatory, GMP and HSE compliance, and are further developed to meet future requirements and business needs. They will also lead the Drug Product Production Unit to manufacture and supply high quality and value clinical material on time, every time, safely, environmentally sustainable and efficiently.
Application Closing Date: 21 May 2024
Your responsibilities:
• Provide servant leadership, strategies, and guidance to the Clinical Manufacturing Drug Product unit comprising of multiple projects, operations, and initiatives by optimally setting up processes and assets to best serve the Development team, as well as the Clinical Supplies worldwide.
• Define and plan all requirements of GMP production with project execution plans for discipline and approve and ensure the proper implementation of production requirements.
• Ensure the DP Unit’s objectives are in compliance with Quality, Customer Service, Health and Safety and regulatory requirements.
• Responsible for short-term planning and achieving goals set within the Clinical Manufacturing Drug Product unit.
• Develop and implement strategy within manufacturing unit aligned with TRD's Clinical Manufacturing strategy.
• Co-Develop and follow-up the required mid and long term strategy for the site in alignment to TRD's objectives and support any ongoing and future strategic initiatives.
• Drive lean production and continuous improvement to enable the production unit’s performance to remain competitive and compliant.
• Develop and leverage communities of practice in operational excellence and for embedding IQP.
• Develop, monitor and report on KPI's and performance measures to enable strategic objectives to be met or remedial actions to be taken. Permanent measurement, benchmarking and continuous improvement of KPI's.
• Support preparation of financial OPEX & CAPEX budget and ensure that the approved budget is met for the relevant unit.
• Economic management of costs, working capital and investments, e.g. by efficient planning and utilization of technical and human resources in the unit.
• Drives the talent agenda. Coaching, leadership, development and motivation of associates. Support of team-building, empowerment and conduct the team to a process oriented organization.
• Accountability for successful product transfers and the organizational development to enable smooth transition and achieve improved performance quickly.
• Acts as an ambassador for the Novartis Culture – Inspired, Curious and Unbossed
The Director Clinical Manufacturing Drug Product, will then lead the site’s Drug Product Process department, and ensure that equipment, infrastructure and manufacturing areas are fully operational, meet regulatory, GMP and HSE compliance, and are further developed to meet future requirements and business needs. They will also lead the Drug Product Production Unit to manufacture and supply high quality and value clinical material on time, every time, safely, environmentally sustainable and efficiently.
Application Closing Date: 21 May 2024
Your responsibilities:
• Provide servant leadership, strategies, and guidance to the Clinical Manufacturing Drug Product unit comprising of multiple projects, operations, and initiatives by optimally setting up processes and assets to best serve the Development team, as well as the Clinical Supplies worldwide.
• Define and plan all requirements of GMP production with project execution plans for discipline and approve and ensure the proper implementation of production requirements.
• Ensure the DP Unit’s objectives are in compliance with Quality, Customer Service, Health and Safety and regulatory requirements.
• Responsible for short-term planning and achieving goals set within the Clinical Manufacturing Drug Product unit.
• Develop and implement strategy within manufacturing unit aligned with TRD's Clinical Manufacturing strategy.
• Co-Develop and follow-up the required mid and long term strategy for the site in alignment to TRD's objectives and support any ongoing and future strategic initiatives.
• Drive lean production and continuous improvement to enable the production unit’s performance to remain competitive and compliant.
• Develop and leverage communities of practice in operational excellence and for embedding IQP.
• Develop, monitor and report on KPI's and performance measures to enable strategic objectives to be met or remedial actions to be taken. Permanent measurement, benchmarking and continuous improvement of KPI's.
• Support preparation of financial OPEX & CAPEX budget and ensure that the approved budget is met for the relevant unit.
• Economic management of costs, working capital and investments, e.g. by efficient planning and utilization of technical and human resources in the unit.
• Drives the talent agenda. Coaching, leadership, development and motivation of associates. Support of team-building, empowerment and conduct the team to a process oriented organization.
• Accountability for successful product transfers and the organizational development to enable smooth transition and achieve improved performance quickly.
• Acts as an ambassador for the Novartis Culture – Inspired, Curious and Unbossed
Diversity & Inclusion / EEO
We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
Role Requirements
• University degree in Biotechnology, Pharmacy or related science (advanced degree in scientific or relevant discipline or equivalent preferred). IQP/Lean education & certification desirable
• 8+ years relevant DP experience in the pharmaceutical industry(Aseptics GMP and/or Technical Development)
• Detailed knowledge of GMP requirements and its applications
• Profound knowledge of industry HSE processes and procedures
• Good project management skills
• Very good understanding of risk management and the use of it
• Applications of Lean Manufacturing principles
• Good understanding of Development processes of NBEs and NCEs and the relevant interfaces for transfer to Clinical Manufacturing
• Good communication skills, ability to effectively present complex ideas and solutions to management, technical experts and regional / local teams
• In depth product knowledge of Biologics (monoclonal antibodies, bi-tri specifics, etc) and their related aseptic manufacturing processes
• Very good understanding of production equipment and ability to evaluate business opportunities and/or remediate risks jointly with relevant teams
• Wide interdisciplinary knowledge with strong financial, and customer focus acumen
Accessibility and accommodation: Novartis is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to perform the essential functions of a position, please send an e-mail to [email protected] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
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
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
• 8+ years relevant DP experience in the pharmaceutical industry(Aseptics GMP and/or Technical Development)
• Detailed knowledge of GMP requirements and its applications
• Profound knowledge of industry HSE processes and procedures
• Good project management skills
• Very good understanding of risk management and the use of it
• Applications of Lean Manufacturing principles
• Good understanding of Development processes of NBEs and NCEs and the relevant interfaces for transfer to Clinical Manufacturing
• Good communication skills, ability to effectively present complex ideas and solutions to management, technical experts and regional / local teams
• In depth product knowledge of Biologics (monoclonal antibodies, bi-tri specifics, etc) and their related aseptic manufacturing processes
• Very good understanding of production equipment and ability to evaluate business opportunities and/or remediate risks jointly with relevant teams
• Wide interdisciplinary knowledge with strong financial, and customer focus acumen
Accessibility and accommodation: Novartis is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to perform the essential functions of a position, please send an e-mail to [email protected] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
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
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
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture
Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network
Development
TECHNICAL R & D GDD
Slovenia
Menges
NVS Farmacevtska Proi. doo
Research & Development
Full Time
Regular
No
395396BR