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【Medical】Technical Operations Scientist /Engineer

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Job Description


The Technical Operations is part of Janssen Supply Chain (JSC) of Johnson & Johnson. This Pharmaceutical Division (TO) is a worldwide organization with members located in the United States, Europe, and Asia Pacific in close vicinity to the Internal Manufacturing Network (MTO) and External Manufacturers sites. Providing Technical Competence and Manufacturing Excellence to Johnson and Johnson’s pharmaceutical environment and product portfolio is the primary focus of TO organization.

Technical Operations is organized in different platforms, each specialized in a defined pharmaceutical science field (Solids, Parenteral’s, liquids & Cream, Devices & Packaging,
….etc.). It functions by assuring and providing technical and scientific support for:
a. Life Cycle Management
b. External/Internal Manufacturing Strategy and Network Configuration
c. External / Internal Manufacturing Support
i. New Product Introduction
ii. Technology Transfer
iii. Trouble shooting escalation support
iv. Technical training
v. Major Cost Improvements and Sites Support
vi. Products Trending and investigations
d. Design to Value Strategy and Manufacturing Network readiness
e. Localization support
f. Process/Equipment Standardization
g. Innovation → New Technology
h. Strategic Business Strategy (L&A and M&A) support

Description:
The Scientist/Engineer of Technical Operations has main responsibilities to specifically focus on External manufacturer / Third-Party Manufacturer located in the Asia Pacific region.

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
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.

Primary Location
Japan-Tokyo-To-Chiyoda-
Organization
Johnson & Johnson K.K. (8235)
Job Function
R&D
Requisition ID
1905769467W