CMC Manager
BeiGene
Guangzhou Manufacturing, China
45分钟前

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 CMC Team and other business partner.Monitor integrated project plans including milestones, timelines, and resources.

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.

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 : BS, MS, or PhD in Pharmaceutical Chemistry, Organic Chemistry, Pharmaceutics, Pharmaceutical Science, Chemical Engineering or related scientific discipline .

5+ years of experience in pharmaceutical or biotechnology CMC management of development programs . Good understanding of all aspects of CMC including process development, regulatory and quality requirements, analytical development, formulation and drug product technologies, distribution across multiple regions.

  • Experienced 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. 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.

    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.

    Good Communication Skills in English and Chinese. Follow Us on MoSeeker!

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