Director Clinical Manufacturing Drug Substance, Biologics (m/f/d)
Novartis
- Mengeš, Osrednjeslovenska
- Nedoločen čas
- Polni delovni čas
- Provide servant leadership, strategies, and guidance to the Clinical Manufacturing Drug Substance 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 his/her discipline and approve and ensure the proper implementation of production requirements.
- Ensure the DS 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 Substance 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
- 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 of relevant DS experience in the pharmaceutical industry (Biologics 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 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
https://www.novartis.com/about/strategy/people-and-cultureYou'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-rewardsJoin 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/networkFunctional AreaResearch & DevelopmentDivisionDevelopmentBusiness UnitTECHNICAL R & D GDDEmployment TypeRegularCommitment to Diversity & Inclusion:We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.Shift WorkNoEarly TalentNo