JanssenScientistEngineer of Techical Operations
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Job Location:
Monthly Salary:
Posted on:
30+ days ago
Vacancies:
1 Vacancy
Job Summary
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 ( / 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.
Key Skills
- Risk Management
- Negiotiation
- Operational management
- Smartsheets
- Strategic Planning
- Team Management
- Budgeting
- Leadership Experience
- Program Development
- Supervising Experience
- Financial Planning
About Company
About Johnson & Johnson A t Johnson & Johnson, we believe good health is the foundation of vibrant lives, thriving communities and forward progress. That’s why for more than 130 years, we have aimed to keep people well at every age and every stage of life. Today, as the world’s larges ... View more
