- East Hanover, NJ
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?
In the role of Technical Steward you will be responsible for providing to the Site the specialist knowledge, as Subject Matter Expert, for the technology activities and transfers at site level!
Oversees processes and standards to maintain and improve existing and to implement new innovative manufacturing technologies.
Provides the documentation and technical expertise for technical transfer of processes.
Your responsibilities include, but are not limited to:
Stewardship - for technology assigned:
•Act as the SPOC for the interface between different sites (clinical production or pivotal facility).
•Owns the knowledge of specific manufacturing process technologies and logistics solutions.
•Participate in the definition and selection of pharmaceutical equipment, through providing input to User Requirements.
•Collaborate with NIBR, technical development, other sites and global MS&T network to facilitate transfer of technical knowledge.
•Collect and trend data generated in the PU and in comparison with development data to support changes, regulatory submissions as well as process performance analysis.
•Be a recognized scientific expert internally and externally by reporting and presenting scientific/technical work at internal/external meetings/conferences and publish in peer reviewed international scientific journals including patents.
•Author or support creation of Quality Risk Assessments.
•Support creation of SOPs for Process Unit.
•Provide technical expertise to Engineering for design activities in Capex projects around technologies within area of responsibility.
•Provide technical expertise for equipment qualification around technologies within area of responsibility.
•Own or assess change controls
•Approve validation reports under their area of responsibility (as needed).
•Provide technical expertise for validation activities around technologies within area of responsibility.
•Maintain Ongoing Process Verification through data trending.
•SME for specific Technology Platform or pharmaceutical processes following process product/process transfer or handover from launch to expansion/late stage production.
•Authoring or reviewing Technology Transfer protocols, reports and related documentation.
•Developing/participate in developing design of Technology Transfer activities to enable accelerated pipeline strategies
Manufacturing Excellence- for the technology(ies) assigned:
•Harmonize and optimize technical processes across the site to enable platform approach
•Benchmark new technologies and equipment relevant for site.
•Design and control optimization projects.
•Provide SME expertise to perform process characterization of the related pharmaceutical processes to increase robustness and sustainability.
•Support Product Stewards / Process Experts / Validation Experts in trouble shooting / root cause investigation by providing second level of specialist expertise as SME and by harmonising and optimising related technical processes across the units.
•Own and/or assess product and asset related changes and provide technical assessments as required
•Perform technical feasibility trials related to process improvement and implementation of new manufacturing technologies.
•Own the Training Curriculum for own Job Profile and direct reports as applicable.
•Provide technical trainings and education programs for Process Experts and production operators.
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 any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.
What you'll bring to the role:
•Minimum 5 year experience in GMP manufacturing relevant to the specialist area of expertise.
•Proven process understanding (Pharma, GMP, Regulatory aspects).
•BSc. in Pharmacy, Pharmaceutical Technology, Chemistry or equivalent scientific degree.
•Knowledge and Experience in Project Management, Validation, Manufacturing, Process & Cleaning
•Collaborating across boundaries Fix-its/Turnarounds
•Quality Change Control Data analytics
Position will be filled commensurate with experience
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.
Join us and help us reimagine medicine.
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