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Job Function:
R&D Product DevelopmentJob Sub Function:
R&D Chemical/Biochemical EngineeringJob Category:
People LeaderAll Job Posting Locations:
Shanghai ChinaJob Description:
Position Summary
Provide brief and concise statement explaining the main purpose for the existence of this position. Provide a brief summary of the role.
Lead the China Biologics Core function including China based API DPD and AD teams.
Collaborates internally with Commercial Operation Regulatory Quality IMSC and other partnering Protein Development functions and externally with Chinese health authorities to drive products launch and ongoing commercial operation in China.
Shape Chinese regulatory strategy through direct projects with Chinese health authorities engagement on Chinese healthcare regulations industry forums participation at meetings and publications & presentations. This is a critical activity as Chinese regulatory policies are changing rapidly.
Ensure rigorous oversight of technical development and GMP operation at CDMOs and CROs based in China. Ensure on time and on quality support of Technical Transfer between China based CDMOs / CROs and Protein Development teams based in the US and Europe.
Ensure on time and on quality support to due diligence of China sourced external innovation and business development projects.
Drives operation excellence and innovation to deliver all tasks with increasing speed and operation efficiency.
Drive change management and shape a winning culture.
Develop coach and engage talents and ensure diverse bench strength for the future.
Engage and contribute to the overall Protein Development strategy and deliverables as a member of the Protein Development leadership team
Major Duties & Responsibilities
In order of importance briefly describe in sentence form the essential functions/major responsibilities of this position (principal duties and responsibilities of the position) as it exists today. Describe the job not the person in the job. Each item listed below should be an essential function/major responsibility of the position not a day-to-day activity.
Typically job descriptions should contain no more than seven or eight major responsibilities ranked in order of highest percentage of time to least.
Approximate Percentage of Time Tasks/Duties/Responsibilities
50% Support product launch and ongoing commercial operation in China
20% Engage Chinese health authorities influence Chinese regulatory policies and shape Chinese filing strategies
10% Management of headcounts and budgets related to functional activities
10% Member of the Protein Development leadership team and contributes to Protein Developments strategic and long-range planning
10% Participate various J&J Chinese leadership committees and forums
Required Minimum Education: Masters Preferred Minimum Education: PhD
Required Years of Related Experience: >15 years experience in Biopharmaceutical Development with demonstrated success in engaging Chinese health authorities and shaping Chinese health regulatory policies. Extensive experience of working with China based CDMOs and CROs.
Required Knowledge Skills and Abilities: Fluent in English and Chinese
Percentage Traveled: 30% Domestic (China) and International
Required Years of People Management Experience: >10 years
Preferred Area of Study: Biochemistry Biochemical Engineering or relevant disciplines
Preferred Related Industry Experience: Pharma or Biotech
Preferred Knowledge Skills and Abilities: Experience working with international teams
Key Working Relationships
Internal
IMSC RA QA Commercial Operation and API DPDD and AD within Protein Development
External
Chinese Health authorities Contractors CDMO and CRO
Required Skills:
Preferred Skills:
Biochemical Engineering Chemical Engineering Critical Thinking Developing Others Disruptive Innovations Efficiency Analysis Financial Competence Global Market Inclusive Leadership Leadership Performance Measurement Process Chemistry Process Optimization Product Improvements Quality Assurance (QA) Research and Development Researching SAP Product Lifecycle ManagementRequired Experience:
Exec
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