Director, Vaccines Process Science & Standardization / Leiden

Organisatie: Johnson & Johnson
Locatie: Leiden
Functie: Director, Vaccines Process Science & Standardization
Vervaldatum: 01/07/2021
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Janssen Supply Chain (JSC) Technical Operations is recruiting a Director, Vaccines Process Science & Standardization. We are open to consider the role to be based at any of our JSC sites, with strong preference for the following countries or sites: Titusville (NJ) and Malvern (PA) United Status or Leiden, The Netherlands. Alternative JSC sites will be considered, including Cork (Ireland), Schaffhausen (Switzerland), Beerse (Belgium), etc.

At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com and follow us @JanssenGlobal. Janssen Supply Chain, LLC, is part of the Janssen Pharmaceutical Companies.

The Technical Operations (TO) Director, Vaccines Process Science & Standardization, is responsible for providing leadership as well as strategic and tactical direction and accountable for proper allocation of resources, from a TO Platform or cross Plant level to meet Platform objectives and support key stakeholders. Leads cross functional teams to develop and deliver high value solutions required to achieve goals in technology, facilities, processes and products in the vaccines focus areas for Global Technical Operations. 

This individual will provide technical and scientific process support and leadership to our vaccines value chains end-to-end and integrate Manufacturing Operations (Internal and External) with R&D in partnership with Value Chain Management. This individual will lead teams and partner with R&D to define manufacturing process and technology standards to enhance reliability, compliance & efficiency in the vaccines supply chain network. The individual will also drive knowledge management for the newly formed TO Vaccines technology platform.

Principal Responsibilities:

  • Develops and deploys together with a cross functional team, manufacturing and technical process standards for the vaccines supply chain 
  • Provides technical and scientific process expertise to global New Product Introduction (NPI) for Vaccines through E2E Technical Product Sourcing Evaluations and support of Tech Transfer activities
  • Drives knowledge management in collaboration with TO Business Optimization, for the TO Vaccines technology platform – i.e. providing guidance to Communities of Practice, establishing and maintaining processes for knowledge building and sharing, developing Playbooks for processes and manufacturing technologies.
  • Partners with R&D and Manufacturing leadership to optimize processes and flows in the Vaccines manufacturing area and supply chain
  • Provides technical and scientific leadership for Life-Cycle Management
  • Owns and executes Initiatives and technical projects related to network configuration, major cost improvement programs, implementation of new capabilities and capacity
  • Contributes to business planning strategies in partnership with Manufacturing Leadership and translates business goals into Technical Operations objectives
  • Approves and monitors the TO Vaccines platform budget
  • Develop relationships with key stakeholders: i.e. JSC Make partners, R&D, Quality, Value Chain Management
  • Coaches, mentors and provides developmental opportunities to staff, evaluates performance and initiates corrective actions when necessary
  • Deep understanding of biotechnology pharmaceutical and manufacturing processes, as well as specific vaccines dosage forms, based on scientific and engineering principles
  • Deep understanding of related science: data analytics, modeling, statistics, advanced process controls, material science
  • Deep understanding of GMP, QA, Regulatory expectations and guidelines for biologics and vaccines
  • Deep understanding of scale-up and plant operations
  • Understanding of pharmaceutical product development and life cycle management 
  • Operations experience and good understanding of operational Excellence
  • Innovation mindset
  • Comprehensive knowledge of supply chain E2E (products, customers, suppliers, plants) especially for involved technology platform
  • Familiarity with Facility and Utilities Engineering and Management 
  • Ability to lead cross functional / cross-platform project team
  • Ability to manage complexity and change
  • Ability to interact and communicate at different levels of the organization 
  • Ability to work under pressure, handle conflicting interests, and take decisions
  • Ability to work independently under general direction, having a good sense of prioritization of assigned tasks goals and manage time accordingly
  • Strong knowledge of Quality & Compliance and regulatory requirements (GMP / EHS), specifically for biologics
  • Good Manufacturing Practices (GxP): Adhere to applicable cGxP’s and procedures (role model)
  • Environment, Health & Safety (EH&S) Adhere to applicable EH&S procedures
  • Qualifications

  • A minimum of a Master’s degree in Natural Sciences/Pharmacy or Engineering (or University equivalent) is required. An advanced degree is preferred
  • A minimum of 10 years related experience is required
  • Strong theoretical and practical expertise in biotechnology manufacturing processes – vaccines and large molecule dosage forms, focused on engineering, new product development, manufacturing processes, materials aspects, packaging
  • Strong knowledge of Quality & Compliance and Regulatory requirements – (GMP/EHS), for biologics
  • Experience in Operational Excellence
  • Experience in Operations Business Unit Management 
  • Understanding of pharmaceutical product and process development within R&D as well as life cycle management 
  • This position may require up to 25% domestic and international travel
  • Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability

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