Director, CMC Drug Product

Leads and guides formulation scientists to advance DP Projects through effective leadership in a matrixed, multi-disciplinary team, coordinating with various functions: project management, analytical, drug substance, pilot plant, quality, regulatory, supply chain, nonclinical safety, DMPK etc.

Accomplishes long and short-term project goals by identifying, justifying, and directing resources needed to deliver the project by working closely with functional leaders.

Oversees formulation and process development for clinical studies and commercialization. Provides guidance for drug product development and supports regulatory filing/addresses agency queries balancing business objectives.

Identifies and/or engages internal expertise to troubleshoot key issues; identifies and utilizes appropriate external experts and resources to advise and advance project.

Stays current with relevant scientific advances and competitive landscape for dosage form development and identifies, evaluates, and champions external opportunities for competitive advantages.

Mentors staff and peers and exemplify through appropriate behaviors, approaches, best practices, and leadership. Holds self-accountable for performance; recognizes and rewards individual and team excellence.

Will be responsible for managing cross-functional CMC activities, providing technical leadership, and ensuring compliance with regulatory requirements，identify and mitigate risks related to CMC activities, ensuring proactive problem-solving and contingency planning.

Qualifications

- Advanced degree Ph.D. in Chemistry, Chemical Engineering, Pharmaceutical Sciences, or a related field.

- Minimum of 10 years of experience in small molecule CMC development within the pharmaceutical industry.

- Solid understanding of physical pharmacy, oral absorption, and science/engineer principles that underly pharmaceutical formulation and process development. Strong expertise in oral solid dosage form development.

- Deep cross-functional business knowledge to drive small molecule drug product development, including drug substance, analytical, manufacturing, quality and regulatory affairs.

- Proven track record of successfully leading CMC activities for small molecule drug products from early development through commercialization.

- Strong knowledge of regulatory requirements and guidelines related to CMC (e.g., FDA, EMA, ICH).

- Excellent project management skills, with the ability to manage multiple projects simultaneously.

- Exceptional communication and interpersonal skills, with the ability to work effectively in a cross-functional team environment.

- Experience with CMO management and technology transfer is highly desirable.

百济神州全球胜任力

当我们通过以下十二项全球胜任力，展现出 "患者为先"、"无界协作"、"锐意创新 "和 "追求卓越 "的价值观时，我们就能帮助全世界更多患者获得更多负担得起的药品。

●团队协作

●提供并征求坦诚及可行的反馈

●自我认知

●兼容并蓄

●积极主动

●开拓精神

●持续学习

●拥抱变化

●结果导向

●分析性思维/数据分析

●卓越财务

●清晰沟通

BeOne Global Competencies

When we exhibit our values of Patients First, Collaborative Spirit, Bold Ingenuity and Driving Excellence, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.

●Fosters Teamwork

●Provides and Solicits Honest and Actionable Feedback

●Self-Awareness

●Acts Inclusively

●Demonstrates Initiative

●Entrepreneurial Mindset

●Continuous Learning

●Embraces Change

●Results-Oriented

●Analytical Thinking/Data Analysis

●Financial Excellence

●Communicates with Clarity

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. Drives and communicates strategy, identifies and justifies resources, solves project issues and implements novel scientific/technological solutions. Adheres to defined timelines and manages team.