Full Time

Associate CMC Director/ CMC副总监

Posted 1 month ago
Application ends: November 15, 2021
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Job Description

BeiGene continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.

Job Description

  • Serves as the primary liaison between the Program Core Team and the CMC Team / Technical Operations
  • Develops and oversees execution of integrated project plans including milestones, timelines, resources and budgets.
  • Accountable for availability of clinical and commercial supplies, timely development of high-quality regulatory filing content, development of robust manufacturing processes and analytical methods and completion of all necessary validation activities within a matrix structure with the expertise areas and external partners in order to deliver new drug applications in multiple markets.
  • Actively manages aspects of regulatory submissions (IND, NDA, etc.) and interactions, launch readiness for relevant products in close collaboration with Technical Operations, Regulatory, Program Management, Finance and other involved departments.
  • Leads development and implementation of post-launch product life-cycle management, e.g., alternate production sources and scales, alternate packaging etc.
  • Ensures effective communication and collaboration of all involved functions and third parties.
  • Establishes a culture of open communication and effective collaboration, drives to agreement but willing to take a stand when necessary.
  • Represents Technical Operations at upper management review and decision-making meetings.
  • Proactively manages risk and drives project related decision to ensure teams are successful in achieving their goals and team milestones.
  • Project management skills
  • Strong interpersonal communication skills, including persuasion and mediation

Qualification Required

  • 8+ years of experience in pharmaceutical or biotechnology CMC management of development programs
  • Broad understanding of all aspects of CMC including process development, regulatory and quality requirements, analytical development, formulation and drug product technologies, distribution across multiple regions.
  • Extensive experience in managing US and International CDMOs for the manufacture of cGMP drug substance and drug product
  • Experienced with cGMP manufacturing and IND and NDA filings; good working knowledge of relevant FDA, EMEA and China regulations
  • Proven track record of superior interpersonal and communication skills with ability to develop strong positive relationship with senior management as well as all levels of the organization.
  • Ability to operate effectively within an entrepreneurial and science-driven company environment; self-motivated, delivery-oriented, assertive, able to inspire others, driven and hands-on with unquestionable integrity and the highest ethical standards
  • Proven experience in managing teams, budgets and resources
  • Project management skills
  • Proven ability for strategic thinking in a complex business environment
  • Ability to deal with ambiguity

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