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USP/DSP Lead Technician (CAR-T) // Johnson & Johnson

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USP/DSP Lead Technician (CAR-T) // Johnson & Johnson

Caring for the world ... one person at a time inspires and unites the people of Johnson & Johnson. This culture of caring is the focus of our corporate philosophy, that is anchored in the internationally applicable Credo. We embrace research and science - bringing innovative ideas, products and services to advance the health and well-being of people. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout the world. We have more than 260 operating companies in more than 60 countries employing approximately 134,000 people. Our worldwide headquarters is in New Brunswick, New Jersey, USA.

Janssen Vaccines in Bern (Switzerland) belongs to the Janssen Pharmaceutical Companies of Johnson & Johnson. Janssen is an organization of over 30,000 professionals working passionately to prevent, treat, cure and stop some of the most devastating and complex diseases of our time. In Bern, about 300 people of over 20 nationalities work together with the wider Janssen organization and partners on the development, manufacturing and analytical testing of novel vaccines and bacteria-based pharmaceutical products. We are committed to bringing meaningful innovation to global health by combating major threats to the health of people worldwide.

Main Responsibilities

  • Execution of the practical USP & DSP project work within a cGMP regulated environment
  • Accurate reporting and interpretation of batch manufacturing results. Conclude on results in consultation with the process engineer or the scientist/team leader contributing to campaign reporting and to process and operational improvement
  • Carry out development and manufacturing activities according to predefined study plans or batch records complying to the defined timelines
  • Carry out core USP & DSP processes complying to cGMP regulations
  • Support and help troubleshoot purification operations
  • Support process/cleaning qualification and validation work
  • Establishment and ownership of SOPs and manufacturing protocols
  • Support safety and environmental initiatives by testing equipment prior to starting production
  • Report EHS gaps and/or incidents and initiate EHS improvements
  • Document the executed work in protocols and batch records in accordance to good documentation practice
  • Plan the execution of work packages and manufacturing operations as well as side activities
  • Perform manufacturing raw materials/consumables reservations in ERP system
  • Take part in establishment and provide feedback to study plans, study reports, SOPs, MBRs, technical and equipment maintenance/calibration reports
  • Report quality documentation gaps and act upon them depending on defined responsibilities
  • Implementation and introduction of new processing techniques and manufacturing equipment and/or coordination of equipment improvements and modifications
  • Communication with external parties for purchase of new equipment and materials
  • Support equipment qualification and computerized system validation activities
  • Internal organization of assigned pilot plant facility suites including implementation of safety procedures as well as house-keeping activities (log books, cleaning protocols, etc.) in accordance to cGMP regulations
  • Reporting of non-conformances and initiation of quality issue records and low impact investigations as well as corrective actions under cGMP

Who we are looking for

  • Higher education, BSc or MSc in a life sciences discipline (pharma/biotechnology, food, chemical or equivalent)
  • Professional work experience as technician with leading responsibilities or equivalent in the life sciences field in a cGMP environment is a major plus
  • Flexible, adaptive and a team player
  • Ability to work independently and self-disciplined to meet the given timelines
  • Strong communication in German and English
  • Previous experience or knowledge with updsteam or downstream pharma processing operations is a major plus

This job based in Bern, Switzerland will initially be limited to approx. 12 months. If you are interested in working for a global leading health care company in a challenging role, then send us your application in English today. Or give us a call if you have any questions on 058 231 57 94!


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