Job Description

This role is to provide site technical ownership at prioritized EMs and to closely work with internal/external partners to deploy life cycle management (LCM) and new product introduction (NPI) plan in line with product roadmap and supply chain strategy.By closely working with key business partners from Partnership & External Supply (PES), Quality, Procurement, Value Chain Management (VCM), R&D, EHS and MSAT functional teams, this role will actively participate and contribute to different stages of supplier management.l Site Selection: Support technical assessment and evaluationl On-boarding: Support process-fit-to-plant (PF2P) and technical transferl Engage: Lead (or support) technology deployment at EM sites according to Product Roadmap and provide on-site support for technical escalations/InvestigationsDisengage: Support disengagement strategyResponsibilities:

• Be the primary contact for technical issues related to assigned CMO sites and be a key member of Virtual Management Team (VMT).
• Closely working with Technical Owner and (or) Technical Launch Integrator (TLI) to accomplish site-to-site technical transfers and be responsible for site activities of registration and validation campaigns.
• Promote \xe2\x80\x9cSmart Technology Transfer\xe2\x80\x9d concept and coach suppliers to deploy as per Janssen best practices.
• Develop good understanding of current status of ongoing and future planned technical activities at the site.
• Bring technical insights to deviation investigation & technical issue escalation within VMT to assure timely resolution.
• Coach and support EMs to handle troubleshooting / investigation with profound process understanding.
• Maintain and follow up action log with observations / suggestions to drive manufacturing excellence by improving operation/process efficiency, process robustness and intensity.
• Coach and support suppliers performing process data analysis, process modelling (with Global SME support) and statistical process control in order to characterize process capability and to increase process understanding.
• Follow-up/review/approve documents ( e.g. , protocol, report, batch record) upon request.
• Evaluate supplier-initiated change initiatives from technical perspective.

• Owner of technical section in Account Plan for assigned EMs and engage other MSAT roles at the site to keep corresponding part updated.
• Monitor and communicate supplier performance against established metrics. Develop and follow up improvement plans for supplier performance in collaboration with PES team.
• Participate at annual strategy meeting with PES Site Lead and CMO management to discuss long-term strategy for the site.

• 10-15 years\' experience in a cGMP API manufacturing environment.
• Experience in developing/ introducing/scaling-up chemical processes and managing/overseeing commercial production.
• Good project management skills in process know-how transfers.
• Statistical skills required to perform process data analysis/process modelling/SPC.
• Deep understanding of typical unit operations and related process equipment
• Trouble-shooting experience/ Affinity with related methodologies.
• Must have cross-cultural mindset
• Must be highly skilled at collaboration and comfortable working in a matrix organization.

• Minimum requirements: University Degree. Desire MSc or PhD in Chemistry / Chemical Engineering / Biotechnology / Pharmaceutical Science, etc.

• Fluent in written and spoken English.

• SUMMIT
• Deviation/Event/Investigation/CAPA Management System (TrackWise or equivalent)
• Document Management Systems (Truvault, SharePoint, ...)
• Concur
• Workday

• Works in an international environment across different time zones
• Frequent travel required
• Travel: Min 25% - project dependent

Johnson & Johnson