Wir suchen für unseren Kunden WuXi Biologics am Standort Wuppertal (auf dem Bayer-Gelände) einen Upstream 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 an Upstream Leader you will work closely with the MT and MSAT (Material Science & Technology) teams to ensure the effective and efficient tech transfer of products and processes.
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 Upstream 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 Upstream 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 Upstream 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 Upstream processing
- 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
- Experience in CIP, SIP, clean room and water system (Purified Water, pure steam, and WFI)
- A proficiency in operating a drug substance commercial manufacturing facility and/or a pilot plant
- Expertise and specific experiences modelling bioreactors applying oxygen mass transfer, power per volume, carbon dioxide stripping models, vessel mixing characterization, eddy size application, hydrodynamic shear, etc. is preferred
- A strong background in cellular metabolism, various mammalian cell lines, and be scientifically minded
- Hands-on experience with various size bioreactors (both single use bioreactor (SUB) and traditional SS tank) and applying the previously mentioned techniques across those scales is desired
- The individual need to have good understanding in DQ, FAT, SAT, IQ, OQ, & PQ (commissioning and qualification)
- BSc, MSc or PhD in Chemical Engineering, Bioscience, or Biotechnology. Masters level qualification would be advantageous
- A strong leader with the ability to adapt to daily challenges of a manufacturing work environment while maintaining positive and productive attitude and fostering this attitude among direct reports
- Excellent verbal and written communication and presentation skills
- Excellent interpersonal skills with the ability to work effectively with staff at all levels of the organisation
- Ability to work on own initiative and be proactive
- Results oriented, with the ability to manage multiple priorities in a short period of time
- Excellent organisational and planning skills and strong attention to detail
- 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).