Facilitator
Job Description 350+ trials, about 25.000+ patients per year! TRDFW Pilot Plant Aseptics manufacture clinical trial drug products across the entire Technical Research and Development (TRD) portfolio. Our aspiration is to be the partner of choice for delivering safe and effective drug products through innovation, with reliable quality, cost and time effectiveness for our partners and patients. You as Faciliator will be a key player to help us delivering our ambitions.
What you'll be doing:
* Work cross functionally with Quality, Strategy & Operations, Supply Chain, the different NCE & Biologics teams, to ensure an efficient set up of people, assets, tools in order to best serve business needs consistently and with high quality.
* Make sure that all deliverables are achieved against agreed upon timelines and with committed resources and budget. Ensure that all solutions and products are delivered in compliance with all pertinent corporate and legal guidelines on HSE and quality requirements.
* Coordinate HSE and Quality audits in your responsibility area and ensure that all systems & processes are in compliance and audit readiness is given any time
* Facilitate and promote a high performance teamwork environment with a culture of empowerment, curiosity, accountability and servant leadership.
* Provide servant leadership, strategies and guidance to the Pilot Plant Unit in Global PHAD Specialty Unit comprising of multiple projects, operations, and initiatives by optimally setting up processes, assets to best serve the Formulation and Process Development organization as well as the Clinical Supplies worldwide. Ensure timely operational excellence, delivery of high quality products and process knowledge.
Your Key Responsibilities:
*
Support the Pilot Plant Head in coaching, guidance, reporting and coordination activities between PHAD PDU Specialty & Site Leadership Teams, Pilot Plant Team Leads and other stakeholders to implement the Global NCE strategy and ensure that the manufacturing plan is executed in a compliant (GCA, FDA, SOX, OSHA), efficient, and cost effective manner.
* Lead Operational Excellence and coordinate OPEX Plan to ensure operational objectives are met or exceeded. Implement holistic KPI reporting, improving and synchronizing the end-to-end business process, set appropriate priorities and provide monthly business reports in coordination with BPA department.
* Ensure the development of manufacturing & packaging processes and bulk clinical supplies for the development pipeline projects and transfer processes to NTO to ensure timely launch.
* Coordinate and support the capacity ramp-up, including facility, people, and process readiness to ensure a successfully production start. EEO Statement The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential. Minimum requirements What you'll bring to the role:
* Advanced degree in chemistry, pharmaceutics or related science. (Ph.D. in scientific discipline preferred).
* 10 years of successful performance and track records in the role of Sr. Process Expert or Project Leader in a related industrial area (e.g., TRD, NTO)
* Proven track record of successfully managing interfaces to other functions.
* Experienced functional/project leader of global teams with proven track record, including Stakeholder management
* Sterile operation management experience required including knowledge of Quality management, Supply Chain excellence and Operational Excellence
Why consider Novartis?
799 million. That's how many lives our products touched in 2019. And while we're proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people's lives?
We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment. Where you're given opportunities to explore the power of digital and data. Where you're empowered to risk failure by taking smart risks, and where you're surrounded by people who share your determination to tackle the world's toughest medical challenges.
Imagine what you could do at Novartis!
Commitment to Diversity & Inclusion:
Novartis embraces diversity, equal opportunity and inclusion. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.
*Some restrictions on flexible working options may apply and will be discussed during interview if applicable.
Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis Network here:
https://talentnetwork.novartis.com/network
Accessibility and reasonable accommodations
The Novartis Group of Companies are 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 application process, or in order to perform the essential functions of a position, please send an e-mail to tas.nacomms@novartis.com call +1 (877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
https://www.novartis.com/careers/careers-research/notice-all-applicants-us-job-openings Division Global Drug Development Business Unit TECHNICAL R & D GDD Work Location Fort Worth, TX Company/Legal Entity Novartis Pharmaceuticals Functional Area Research & Development
|
Novartis Group Companies
May 19, 2022