Site Operation Head - Saluggia, Italia - Novartis

Novartis
Novartis
Azienda verificata
Saluggia, Italia

1 settimana fa

Piero Bianchi

Inviato da:

Piero Bianchi

Reclutatore di talenti per beBee


Descrizione
Job Purpose
Leads the Site's MS&T organization, which is responsible to maintain and improve the scientific oversight of the

manufacturing processes and technical changes, the relevant technical knowledge and capabilities at the Site and toensure the product and technical stewardship, across process units and functions at Site.


Your key responsibilities:


Your responsibilities include, but are not limited to:

  • Set objectives and develops vision for department.
  • Act as SPOC for site head and MS&T platform/ cluster head.
  • Manage the MS&T career path, succession planning, training program and career progression within the site.
  • Enable knowledge management for processes and products within department and across site functions.
  • Reporting acc. to QM, NTO LT, quality cockpit, Global MS&T.
  • Define and implement standards for MS&T (e.g. local SOPs, templates).
  • Ensure overall inspection readiness for area of responsibility.
  • Ensure robust product stewardship for all products manufactured at the site, and endtoend technical oversight of product manufacturing processes, at all stages of their commercial lifecycle. Ensure that all products, processes, unit operations are assigned to a product steward / technical steward / process expert / packaging expert.
  • Ensure that all manufacturing processes are robust respectively process improvement projects acc. to project plan are implemented.
  • Works across Process Units and Functions within the Site and in close collaboration with MS&T global team to resolve issues and to ensure process capability.
  • Safeguard, maintain and develop the scientific information of product processes.
  • Host site Manufacturing Robustness Review Board (MRRB).
  • Ensure oversight of technical changes and lead endtoend change control management related to relevant technical issues, working crossfunctionally as required.
  • Support excellence in manufacturing through standard setting and technical capability development and deployment.
  • Ensure technical excellence in operational startup for new manufacturing equipment and areas.
  • Ensure collaboration with OPEX for product / process improvements (harmonized agenda & priorities).
  • Support and, where appropriate, lead optimization of pharmaceutical processes by deploying the specialist scientific and technical competence, triggering post launch development, when needed.
  • Ensure the site has set and rigorously applies appropriate technical standards for processing, packaging and materials, where applicable, employing new/modern processes and technologies (e.g. Quality by designQbD, Design of Experiments-DOE, Process Analytical Technology-PAT).

Commitment to Diversity & Inclusion:


  • We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve._

Minimum requirements

What you'll bring to the role:

  • MSc. in Science, Pharmacy or Chemical Engineering, Pharmaceutical Technology or equivalent experience. Ph.
D. desirable.

  • Fluent in English and proficient in site local language.
  • Minimum 10year experience in manufacturing.
  • Additional specialist experience is preferred (e.g., pharmaceutical formulation, process development, manufacturing technology).
  • Proven experience driving quality and compliance in an organization.
  • Strong working knowledge of applied statistics, quality systems and regulatory requirements across multiple health authorities.
  • Fundamental understanding of standard pharmaceutical analytical testing.

Why Novartis?

766 million lives were touched by Novartis medicines in 2021, and while we're proud of this, we know there is so much more we could do to help improve and extend people's lives.

We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation.

That a diverse, equitable and inclusive environment inspires new ways of working.
We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility.

And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world's toughest medical challenges.

Because the greatest risk in life, is the risk of never trying
Imagine what you could do here at Novartis


Division
Oncology


Business Unit

ADVANCED ACCELERATOR APPLICATIONS

Country
Italy


Work Location
Saluggia


Company/Legal Entity
AAA Italy Srl.


Functional Area
Technical Operations


Job Type
Full Time


Employment Type
Regular


Shift Work
No


Early Talent
No

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