• 招聘类型：社招
• 工作性质：全职

职位描述

• Manage activities at CMOs on drug product manufacturing to support for NDAs and commercialization of BeiGene’s products
• Coordinate with API and supply chain functions to make drug product manufacture plans
• Implement GMP drug product manufacturing at CMOs to fulfill both clinical and commercial demands.
• Review and update batch records, SOPs, development reports and related CMC documents. Ensure all applicable GMP guidelines are adhered to the manufacture of oral solid dosage form.
• Draft and prepare technical reports and summaries regarding drug product development and manufacture
• Provide decisive leadership and operational expertise to ensure successful manufacture of the drug products.
• Draft and review IND/NDA documents on drug substances and drug products
• Ensure all R&D activities related to drug products follow industrial standards (eg., ICH, USP, ChP) and regulatory guidance to support IND and NDA filings.
• Lead teams to develop formulation, improve process and ensure smooth tech transfers for larger scale productions.
• Provide constructive guidance in pharmaceutical formulation/analytical work; Coordinate the activities of product evaluation, stability study, method development and validation to establish specifications for raw materials and finished dosage forms.
• Work closely with other CMC team members to prepare and host inspection/audit required by health authorities.
• Work with other functions, such as QA/QC, RA, clinical and supply chain, to schedule manufacturing activities to support clinical trials
• Given the complexity of this role, it is important that the candidate has demonstrated successful leadership, management and mentorship of high-performing teams.

任职条件

• PhD with 8+ year experience in pharmaceutical research & development and drug product manufacturing operation in small molecules.
• Hands-on experience on OSD formulation development, tech-transfer, process scale up, and manufacturing of drug product
• Familiarity with HME, spray dry and others, experience on injection is a plus
• Familiarity with regulatory guidance and GMP compliance
• Experienced in CMC document preparation for IND and NDA
• Track record of successfully engaging and leading teams to solve challenges and commercialize drug products
• The candidate should be a very effective communicator, interacting with key stakeholders, regulators and other technical lines and matrix teams.
• Fluent in both Chinese and English is a plus.

职位要求

• 学历要求：博士
• 工作经验：无
• 外语要求：English

公司福利

• 五险一金 
• 晋升空间 
• 法定节假日