北京招聘

? 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.
职位要求：
? 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.

百济神州是一家立足于科学的全球性生物科技公司，专注于开发创新、可负担的药物，旨在为全球患者改善治疗效果，提高药物可及性。目前公司广泛的药物组合包括40多款临床候选药物。公司通过加强自主研发能力和合作，加速推进多元、创新的药物管线开发。我们致力于在2030年前为全球20多亿人全面改善药物可及性。百济神州在全球五大洲打造了一支超过8,000人的团队。