Technical Steward USP

Key Responsibilities:

Stewardship - for technology assigned

• Act as the SPOC for the interface with global MS&T network and with technical development organization, for the corresponding global activities, to define and implement new technical standards for existing and new technologies and equipment.
• Owns the knowledge of specific pharmaceutical manufacturing process technologies, locally, including any pilot scale, scale up or down, and Design of Experiments (DoE).
• Participate in the definition and selection of pharmaceutical equipment, through providing input to User Requirements.
• Collaborate with technical development, other sites and global MS&T network to facilitate transfer of technical knowledge.
• Assure 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.
• 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.
• Maintain their work in inspection readiness level.
• Support Product Stewards in 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

Validation

• Approve validation reports under their area of responsibility (as needed) e.g. packaging validation.
• Provide technical expertise for validation activities around technologies within area of responsibility.

Launch & Transfer

• SME for specific Technology Platform or pharmaceutical processes following process product/process transfer or handover from launch to commercial production.

Manufacturing Excellence–for the technology(ies) assigned

• Harmonize and optimize technical processes across the site.
• Benchmark new technologies and equipment relevant for site.
• Designs and controls optimization projects.
• Provide SME expertise to perform process characterization of the related pharmaceutical processes to increase robustness and sustainability.
• Support Product Stewards / Process 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.
• Perform technical feasibility trials related to process improvement and implementation of new manufacturing technologies.

Training

• Own the Training Curriculum for own Job Profile and direct reports.
• Provide technical trainings and education programs for Process Experts and Production Operators.

Novartis Manufacturing Manual

• Support implementation of Novartis Manufacturing Manual principle 3.
• Provide SME input to Novartis Manufacturing Manual principle 4.
• Represent site in technical stewardship network.

Essential Requirement:

• Minimum 8-year experience in GMP manufacturing relevant to the specialist area of expertise.
• Proven process understanding (Pharma, GMP, Regulatory aspects).
• Education & Qualification • BSc. in Pharmacy, Pharmaceutical Technology, Chemistry or equivalent scientific degree.
• Desirable MSc. or equivalent experience

Languages

• Fluent in English and proficient in site local language

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