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Johnson & Johnson 职业机会

scientist

陕西, 中国
R&D


职位描述

Requisition ID: 1905735249W

 • Contribute in Developing and deploys technology standards and its applications through assets and products 
• Provides technical expertise to External manufacturing in ensuring product end to end life cycle Management
 o Technically support product life cycle management (investigation, troubleshooting etc.) partnering with VCM, CMC, PDMS and all JSC functions
 • Provide expertise and resources to other TO platform, upon request, acts as a technical co- ordinator to external manufacturing group / SBS for technical scouting and due diligence for the current product portfolio / in-licensing.
 • Owns and executes Initiatives and projects related to network reconfiguration, major cost improvement programs, process improvements, implementation of new capabilities and capacity
 • Contributes to business planning strategies in partnership with PES Manufacturing and PES Regional Lead and translates business goals into project objectives.
 • Develop relationships with Key Stakeholders, like PES Regional Lead, PES Site Lead, ESI-Q, PDMS, TO Platforms, Quality, VCM, CM, PM …...
o Provide and organize technical expertise to External Manufacturing in ensuring consistent production of J&J marketed pharmaceutical products manufactured by External manufacturer / Third Party Manufacturers.
 o Act as a technical co-coordinator and consultant to the PES, PM and CM organizations to support technically in the scouting and due-diligence for the current product portfolio existing in external manufacturing
 o Provide technical expertise to the CM and PES organizations for localization / Glocalization and supporting in due diligence of facility and products/ process fit technical assessment. 
o Assess and support, in agreement with PDMS organization (R&D), the execution for technical manufacturing process /formula modifications and introduction of New Product and Second Generation Development (in alignment with TLI or assuming the role of TLI/DPTO).
 o Assess and support PDMS in innovation of new technology scouting, novel manufacturing etc.
 - Support technical assessment,
 - Building business case,
 - Support the implementation.
 • Lead the Technology Transfer activity of drug products as per regional Guidelines & J&J Quality Standards according to approved budget and timeline;
 o Prepare and ensure technical project scope and align with all stakeholders during project definition and execution
 o Prepare and drive timely decisions within the project team and with relevant commercial and operational management
 o Prepare, support and execute local and regional technology transfer projects in terms of project risks, budget, quality/scope and timings according to state-of-the art project management methodology
 o Execute the Process Validations/PPQ as part of Technology Transfer in cGMP environment.
 o Execute introduction and transfer of products to External manufacturer / Third Party manufacturers for worldwide supplies / regional supplies.
 o Execute Technical Assessment & subsequent implementation for minor technical manufacturing process modifications as requested by the Manufacturer or Commercial groups
 • Strives for developmental opportunities and initiates / proactively seeks for corrective actions as necessary. 

资历
• University Degree (M.Pharm / M.Tech in Pharmaceutical Sciences, or Pharmaceutical Engineering, Chemistry or Engineering).
• Fluent in English and with fluency in another major regional language desirable. 
• 8-10 years of experience in Pharmaceutical Development, Scale up, Technology Transfer and /or manufacturing on oral dosage form and topical presentations in the region, in at least two different functions.
• At least two years’ experience in External manufacturing /Third Party Technology Transfers and project management is desirable. 
• Profound Technology understanding of
 o The following final dosage presentations (minimum of two): Oral Dosage forms (Solids and Liquids), Semi-solids, or Parenterals & Transdermal drug delivery systems
 o Pharmaceutical development of the following Oral Dosage forms (minimum of two): Solid Orals, Liquid Orals, Semi solids, Parenterals & Transdermal drug delivery systems (Minimum of two)
 o Global, and Regional regulatory requirements
 o Fair  knowledge  on  Product  development/scale  up/technology  transfer  regulations pertaining to ICH/USFDA/EMEA/Asia Pacific
 o Knowledge on regional pharmaceutical manufacturing environment for Asia Pacific
 o Good Manufacturing Practices, quality and compliance
 o Process Validations / PPQ / CPV
 o Cleaning validation
 • Can prepare strategy and business case for technology transfer projects together with external manufacturing team and operating Companies
 • Understands the needs of the Manufacturing Excellence Locally and Regionally and its platform
 • Applies state-of-the-art project management methodology to manage project risks, budget, quality/scope and timings
 • Can drive execution of project activities in the project team without formal reporting lines
 • Can communicate and network across functions, regions and cultures, especially Asia Pacific and Europe / US 
 • Shows sense of urgency
 • Stays motivated and achieves results in complex organizations with unclear decision- making processes and responsibilities
 • Wants to establish contacts with people from different functions and from different regions and cultures
 • Is willing to travel as required by the business and to work outside regular business hours
 • Is willing to adjust to different cultures and personalities
 • Balances requirements for quality / compliances / science with business needs

主要地点
中国-陕西--
组织
西安杨森制药有限公司
工作
R&D
Requisition ID
1905735249W