Johnson & Johnson Careers
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Manager, Clinical Supply Chain
Requisition ID: 1805627887W
v Process engineering support in process design, process transfer and scale-up (process fit to plant, manufacturing readiness) to meet more stringent project timelines and assure RFT development and execution
v Lead new technology introduction and application at CROs which are neededed by Janssen projects
v Support product delivery by providing process engineering and operational supports and solutions relating to process design and scale up at CROs
v Supervise process transfer from lab to plant, ensuring process scalability and plant readiness
v Assessment of gap in operation and manufacturing capabilities of China CROs, defining strategy and action plans to enhance manufacturing/engineering capabilies in light of long term calaboration with CROs
v Assessment of CRO’s manufacturing capacity availability in accordance with Janssen criteria and business need, proactively advocate necessary mitigation solutions
v Follow up on production planning and scheduling ensuring plant readiness and on-time production
v Review and approve GMP documentation relating to batch production, e.g. MBR, EBR, change request, process development reports, campaign summary…etc.
v On-stie witnessing of process execution ensuring sucess of batch production and providing manfuacturing and engineering consultance as needed
v Leading issue investigation & resolution, change management, relating to plant execution of PDMS projects, jointly working with CROs and other internal parties
v Active player in GMP audit and assessment at CROs, critical contributor in defining and follow up of CAPAs
v Active player in EHS audit and assessment at CROs, critical contributor in defining and follow up of CAPAs
v Operational and engineering guidances on handling of special chemicals/reactions
v Provide technical guidance and supports to CROs in efforts of facility upgrading to improve reliability in compliance in GMP, EHS, process
v Support tech transfer from external party to internal plant as needed by partnering with API development, internal plants, Janssen supply chain, and other external & internal stakeholders
• Education in chemical engineering, chemistry, or other relevant fields. PhD in chemical engineering area is preferred
• Experience and training in chemical proces engineering tools such as Dynochem
• Flouent in in communciaiton in English and Chinese
• Proven record in process upscaling and downscaling at multinational companies or CROs
• Good knowledge about API development and new product/process introduction
• Good understanding of ICH, cGMP, ISPE and other pertinent manufacturing and engineering guidelines and practices
• Substantial experience in working with external manufacturing parties
• Proven capability in project management
J&J (China) Investments Ltd A- Beijing Branch (7075)