【Janssen】Scientist/Engineer of Techical Operations
Responsibilities:
• 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.
Qualifications:
• 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.
The candidate should have the following qualities and core competencies:
• 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.