Band

Level 4

Job Description Summary

Lead all CMC development and submission technical related activities in China including deliverables and resources to support Development China and Biomedical Research China portfolio. Act as local project leader to maximize the organizational value with focus on the China specific project strategy development, clinical supply and submission, approval, launch and market maintenance of Novartis products in China. Build seamless collaboration with TRD global and local line functions, portfolio management and integrate into TRD global project teams to enable TRD as best in class in the industry.

Job Description

Major accountabilities:

• Represent TRD function to participate China Program Team and contribute to the project strategy development ensuring all assigned activities successfully implemented in line with agreed project plan.

• Actively participate and fully integrate into global TRD sub-teams and ensure the project strategy for China specific activities as part of global project plan.

• Support the development of junior co-workers in the team.

• Ensure the committed deliverables for all responsible projects, networks and/or platforms are timely delivered in good quality and full quantity.

• Provides all necessary support to help address and resolve issues. Identifies solutions for remediation in Development China / BR China portfolio.

• Actively contribute to a strong team spirit and the growth of team founded on technical ability, excellence in performance and exhibiting the Novartis values and behaviors.

• Leads CMC special projects and initiatives.

• Highlight the need for training programs, support the establishment of technical and professional skills for the team, and ensure staff training is conducted and properly documented.

• Ensures high quality communication and information flow on status of CMC activities to stakeholders mitigates and manages risks.

• Proactively contribute in workload demand forecast. Ensure resources and resources needs awareness in projects, networks and/or platforms.

Minimum Requirements:
Work Experience:

• Strong technical background in CMC development, experience in new modality development is preferred, including ADC, xRNA, AOC.

• 3-5 year hands-on experience in lab or other development organization.

• Overall >5 years experience in Pharmaceutical Industry.

• Project Management.

• Operations Management and Execution.

• Collaborating across boundaries.

Skills:

• Coaching Skills.

• Project Management.

• Technical Writing.

Languages :

• English.

Skills Desired

Coaching Skills, Data Science, Environment, Experiments Design, Health And Safety (Ehs), Laboratory Equipment, Manufacturing Process, Materials Science, Process Simulation, Sop (Standard Operating Procedure), Technical Writing, Waterfall Model