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Job Function:

R&D Product Development:

Job Sub Function:

R&D Chemical/Biochemical Engineering

Job Category:

People Leader

All Job Posting Locations:

Shanghai, China

Job Description:

An internal pre-identified candidate for consideration has been identified. However, all applications will be considered.

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 Development’s strategic and long-range planning

10% Participate various J&J Chinese leadership committees and forums

Required Minimum Education: Master’s 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 Management