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[Janssen] MSAT (Manufacturing Science & Technology) Senior Manager (Small Molecule Drug Product) - 2406189913W
Description
職務概要Position Summary:
The launch of new technology, products and technical transfers.
The validation process and execution (Process and Cleaning Validation). This includes lifecycle
management of products (including continuous improvement).
current packaging material (primary, secondary and tertiary). Also includes artwork
management.
法規制の順守に関する責任 Regulatory Compliance Responsibilities:
l Adhere to applicable cGxP’s and procedures & local Japanese regulatory requirements.
l Report incidents and deviations
l Propose solution to improve compliance with cGMP’s
l Adhere to applicable EH&S and procedures (role model).
l Correct use of the available personal and protective equipment.
l Reporting of good saves, accidents, incidents, deviations.
l Cooperate on and suggest solutions to improve EH&S.
l Actively promote EH&S, support campaigns/programs such as “Safe behavior”.
主な職務及び主な責任 Major Job Duties and Responsibilities:
Manage Product Transfer /Product Introduction for the Site
l Manage the NPI Manager to ensure:
Ø Products are launched on time and in full.
Ø NPI projects followed the necessary standards.
Ø NPI projects are achieving plans on target. Where gaps/challenges exist provide the necessary support to the team to overcome these challenges.
Ø Manage NPI stakeholders together with NPI manager to ensure issues are escalated
appropriately and that the team is well supported.
l Work with Regional, Global and Local leadership teams to set the vision for the site’s and
region’s technology roadmap.
l Develop the NPI team through regular performance and career conversations.
Validation Processes and lifecycle management
l Manage the Validation (group) Manager to ensure:
Ø Validation processes are followed in alignment with global Janssen procedures as well as
local regulatory requirements.
Ø Validation processes are followed as per standards, including the maintenance of the
Validation Master Plan.
l Lead or support complex failure investigations (escalation of quality or compliance events).
Packaging Engineering
l Manage the packaging engineers/packaging SMEs to ensure:
Ø Evaluate and implement packaging solutions to meet local market requirements.
Ø Correct management of materials against the standard.
Ø Packaging Innovation and new technology introduction.
Inspection Readiness and Execution
l Technical support in partnership with Quality on any regulatory audits and inspections
l Support through the TO team organization audits including preparing and delivering
presentations, explanations, etc.
Organizational Leadership
l Accountable for managing team in accordance to Site and Technical Operations priorities
following the JSC Business Cascade (Budgeting, Resources)
l Motivates and inspires site team to drive significantly increased performance through
technical innovation and change. Provides leadership and development to the team and
ensures there is a diverse pipeline of high performing multi-skilled leaders of the future.
l Drives a Credo-based culture aligned around our guiding principles of servant leadership,
Think Differently, Do Better, innovation, engagement, collaboration and development.
l Handles all aspects of managing personnel, including hiring and terminations. Provides
coaching and development opportunities. Evaluates performance and provides feedback.
Implements disciplinary actions, as necessary.
l Monitoring and continuous improvement of Site Technical Operations KPIs.
Qualifications
教育/経験Education and Experiences: (Essential)
University degree in Engineering or Science
Project management experience
教育/経験Education and Experiences: (Desirable)
Master Degree or Equivalent
FPX (Flawless Project Execution) program experience
知識、資格、及び技能 Knowledge, Qualification and Skills:
Formulation (Desirable), Primary Packaging and Secondary Packaging
API Manufacturing for small/large molecules (Desirable).
Quality Assurance and Regulatory
Strong Ability to operate in a diverse and ambiguous environment.
Ability to think strategically.
Ability to look for win-win situations.
Fluent in English.
Fluent in Local Language ( Desirable)
行動特性（性格・行動力・価値観）Core Competencies:
Credo value of integrity.
Collaboration and team work.
Customer focus.
Comply with EHS rules and procedures.
Technical understanding
Logical and strategic actions
Influence others and make a difference.
Flexible business execution in diverse and ambiguous environments.
Communicate in a clear and concise way
Primary Location Asia Pacific-Japan-Shizuoka-Sunto-Gun
Organization Janssen Pharmaceutical K.K. (7195)
Job Function Manufacturing Engineering
Req ID: 2406189913W