Johnson & Johnson Careers

Manager, Clinical Supply Chain

Shanghai, China
Clinical Supplies


Job Description

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


Qualifications

       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


Primary Location
China-Shanghai-Shanghai
Organization
J&J (China) Investments Ltd A- Beijing Branch (7075)
Job Function
Clinical Supplies
Requisition ID
1805627887W