Head Ms&t - Madrid, España - Sandoz Farmacéutica, S.A.

Sandoz Farmacéutica, S.A.
Sandoz Farmacéutica, S.A.
Empresa verificada
Madrid, España

hace 2 semanas

Isabel García

Publicado por:

Isabel García

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Descripción
As Head MS&T for the External Supply Organization you will provide specialist knowledge, as Subject Matter Expert, for specific pharmaceutical processes or process technologies (e.g.

Global Technical Steward for External Supply Operations (ESO) related topics, Aseptic or Solid processing for galenical processes like film coating, biologics - upstream or downstream, etc).


You will also oversee unit operations, processes, and standards to maintain and improve existing and to implement new innovative manufacturing technologies across platforms.


Your responsibilities will include:
Knowledge Management

  • Provides the knowledge of specific pharmaceutical manufacturing process technologies, globally, including any pilot scale, scale up or down, Design of Experiments (DoE), as well as large scale manufacturing across multiple sites.
  • Supports Site and ESO Technical Stewards/Managers in developing and/or aligning fundamental knowledge in the specific area of expertise. In collaboration with Technical Stewards/Managers ensures alignment and best practices in regular training and education programs provided to Process Experts and Operators.
  • Assures 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 knowhow of the associates and expanding it to the rest of the organization.
Subject Matter Expert (SME) for Platform

  • Provides deep SME expertise globally across sites for processes and related equipment (e.g. galenical, chemical, biologics upstream or downstream, etc) following product/process transfer or handover from launch to commercial production. Designs and controls optimization projects relevant to his/her specific expertise at crosssite level.
  • Sets the standards for SME expertise to perform process characterization of the related pharmaceutical processes to increase robustness and sustainability in collaboration with development organizations and MS&T.
  • Supports Technical Stewards / Managers and Product Stewards in trouble shooting by providing second level of specialist expertise as SME and by harmonizing and optimizing related technical processes across the units and sites globally.
  • Author and implement GOPs for technology assigned.
Single Point of Contact (SPoC) for the technology

  • Acts as the global SPoC for the interface with the Global MS&T network and with the technical development organization, for the corresponding global activities, to define and implement new technical standards for existing and new technologies and equipment (e.g. manufacturing equipment and Process Analytical Technologies (PAT)).
  • Collaborate with technical development, sites, CMOs and the Global MS&T network to facilitate the transfer of technical knowledge.
  • Responsible for setting the standards to perform technical feasibility trials related to process improvements and implementation of new manufacturing technologies.
  • Acts as a global SME for new manufacturing technology.
Selection of Process Equipment

  • Sets input for User Requirements (URS) globally valid, to enable technology management and harmonization across NTO for pharmaceutical equipment.
Audit Support

  • Maintains their work at a global level at inspection readiness level and provides the necessary support in any internal or external audit in addition to providing input to and review of regulatory documentation.
  • Participates in / supports due diligence team, where applicable, for inlicensing projects.
Training

  • Own the Training Curriculum for own Job Profile.
  • Supports the development of training curriculum for Technical Stewards/Managers and assures alignment and best practices across sites. Provides the necessary training and support to new associates joining this position and other roles as needed.
  • Provides the necessary training and education on related technologies to Technical Stewards, Global Product Stewards and whenever a specific expertise is required.
  • Be a recognized scientific expert globally, internally and externally by reporting and presenting scientific / technical work at internal / external meetings or conferences and publishes in peer reviewed international scientific journals, including patents
Sandoz

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

What you'll bring to the role:
MSc. in Pharmacy, Pharmaceutical Technology, Chemistry, Biology or equivalent scientific degree. PhD or equivalent experience desirable.

Fluent in English and proficient in site local language

  • Minimum years experience in GMP manufacturing relevant to the specialist area of expertise
  • Proven process understanding (Pharma, GMP, Regulatory aspects)
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