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Downstream Process Leader (m/w/d)

Wir suchen für unseren Kunden WuXi Biologics am Standort Wuppertal (auf dem Bayer-Gelände) einen Downstream Process Leader (m/w/d).

WuXi Biologics, eines der drei weltweit größten Unternehmen mit einer führenden Open-Access-Technologieplattform für die Entdeckung, Entwicklung und Herstellung von Biologika. Zur Ergänzung der bestehenden Produktionskapazitäten übernimmt WuXi Biologics den Betrieb einiger Produktionsanlagen der Bayer AG in Leverkusen und in Wuppertal für die Herstellung von Arzneimittelendprodukten.

Da es sich bei WuXi um einen international tätigen Konzern handelt und gute Englischkenntnisse Voraussetzung sind, lesen Sie bitte nachfolgend die Stellenausschreibung in Englisch:

Summary of Role
In this role you will report to the Manufacturing Director and play a pivotal role in establishing the Manufacturing Department initially during start-up by supporting operational readiness and providing operations input to ensure the facility design meets end user requirements and latterly, post start-up, by leading the manufacturing team to consistently deliver on specific Key Performance Indicators (KPIs). As a Downstream Leader you work closely with the MT and MSAT (Material Science & Technology) teams to ensure the effective and efficient tech transfer of products and processes to the Dundalk Facility.

Principle Job Responsibilities:

  • Key member of Manufacturing leadership team playing an important role in the strategy and business planning processes, ensuring cross functional collaboration and leadership execution
  • Support the execution of the overall Manufacturing strategy aligned with the facility’s strategic business plans and global Manufacturing strategy
  • Lead a team of Shift leaders, Specialists and operators to execute routine manufacturing activities in the commercial scale manufacturing of therapeutic proteins in a mammalian cell culture facility
  • Supervise daily Downstream manufacturing activities and ensure production timelines are met
  • Collaborate with MT and MSAT groups on technical transfer and process validation
  • Collaborate with QC & QA groups to ensure GMP compliance, manage deviation investigation and CAPA implementation, and support client auditing and agency inspections
  • Provides working knowledge and technical leadership in cell culture operations and schedules and/or delivers training to manufacturing personnel to ensure staff can perform manufacturing operations safely and compliantly
  • Motivate, retain, develop existing group members and recruit new staffs to build a strong Downstream manufacturing team
  • Contribute to continual improvement of all manufacturing documentation (SOP’s MBR’s, OJT’s) to ensure they are current, accurate, and clear
  • Communicate operational status regularly to senior management, as required, at the appropriate level of detail
  • Assist the Manufacturing Director to coordinate the work between the Downstream groups and other functional groups to meet the production objectives and timelines
  • Flexibility to take on additional tasks and responsibilities at the discretion of the Manufacturing Director
  • Acting as a role model for the Manufacturing function and also the wider organisation in adherence to the WuXi corporate core values, local site shared commitments/behaviours

Required Qualifications and Experience:

  • Ideally, experienced in establishing a Manufacturing department and building a team in a ‘greenfield’ context of similar size and scale
  • More than 15 years in biopharmaceutical manufacturing with extensive experience in Downstream processing
  • Experience in the large-scale chromatography, centrifuge and depth filtration harvest, ultrafiltration/diafiltration, and viral inactivation and removal
  • Experience in dealing with FDA, and/or EMA and CFDA, and have a solid understanding of quality system in terms of deviation, investigation, CAPA and change control
  • Knowledge in working with the cross-functional teams
  • Experience in troubleshooting and investigation of the critical deviation, and making the risk analysis on the development, technical transfer and process validation
  • Must be quality focused with knowledge and understanding of cGMP quality systems and how they apply to manufacturing operations
  • BSc, MSc or PhD in Chemical Engineering, Bioscience, or Biotechnology. Masters level qualification is advantageous
  • Must be willing to travel as required internationally to fulfil the responsibilities of the position

Wir freuen uns auf Sie!
Unser Kunde bietet Ihnen ein leistungsbezogenes Einkommen und sehr gute Möglichkeiten zur fachlichen und persönlichen Weiterqualifizierung. Wenn Sie sich in dieser Stellenbeschreibung wiederfinden, bewerben Sie sich bitte per E-Mail mit Ihren vollständigen Bewerbungsunterlagen (Anschreiben, Lebenslauf, Zeugnisse gerne in Englisch).

Ihre Ansprechpartnerin:
HR-Office GmbH
Nivia Moritz
Kohlfurther Straße 65
42349 Wuppertal
Tel. +49 (0) 202 942295 – 95
www.hr-office.eu
nivia.moritz@hr-office.eu

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Telefon

+49 (0) 202 942295 – 95

Fax

+49 (0) 202 942295 – 96

Mail

info@hr-office.eu

Adresse

HR-Office GmbH
Kohlfurther Straße 65
42349 Wuppertal