Job Description:

• 与药化，药效，毒理，CMC，非临床&RA，临床团队紧密合作，提供药代动力学与生物分析相关支持，参与药物发现与开发项目团队会议，在研发过程中从药代动力学角度提出合理建议。
• 负责临床前筛选与申报药代CRO的评估和筛选，以及临床生物分析CRO的评估和筛选。协调CRO，监督CRO有序高效推进工作。负责实验方案与正式报告审核修订，申报资料的审核修订，协助项目申报和临床实验开展。
• 根据临床前药代数据，建模预测人体药代参数，协助临床团队制定临床研究方案。参与审阅临床方案中临床药理药代相关部分实验设计，数据总结，报告撰写等。
• 采用液相色谱－质谱联用开发建立不同基质生物分析方法，进行生物样品分析，支持从临床前至临床相关的生物分析工作。

Qualification:

• 药代动力学相关专业，博士学位或硕士学位，且具备多年工业界药代动力学相关工作经验，硕士至少十年以上，博士至少三年以上。
• 具备体外ADME和体内PK研究的实践经验，熟悉药代动力学研究的专业知识和原理，熟悉PBPK，PK/PD建模者优先。
• 具有生物分析知识和仪器分析经验
• 具有良好的解决问题的能力，协调组织沟通能力以及团队合作精神。
• 具有良好的英语阅读与写作能力。

Job Description:

Qualification:

Job Description:

• Overall responsibility for drug substance and drug product activities from preclinical development through clinical supplies for Phase 3 registration studies. 
• Identification, selection and management of Contract Development and Manufacturing Organizations (CDMOs) for process optimization, cGMP manufacture and supply of Drug Substance (API) and Drug Product (DP).
• Develop and implement strategy and design of experimentation for optimizing and controlling quality of bulk API and DP using CDMO. 
• Delivery of robust, scalable and cost-effective manufacturing routes and drug product formulations that meet or exceed the target clinical profile.
• Projection of API and DP needs for preclinical and clinical programs (with clinical team), and associated budgets (with finance team). 
• Formulation design/development in support of clinical studies.
• Management of supply chain and logistics in support of clinical studies. 
• In coordination with Quality Assurance, implement stage appropriate analytical methods and protocols and ensure that all CDMOs are using systems and processes in compliance with all relevant regulatory standards.
• Execute plans for the validation and registration of API and DP as required by cGMP, ICH (International Conference of Harmonization) and NMPA / FDA regulations. 
• Writing and reviewing documents for INDs / regulatory section submissions; represent the company as the CMC expert before China and U.S. regulatory authorities. 
• Prepare, review or edit cGMP batch records, CMC regulatory and Quality documents. 
• Prepare technical reports, publications and oral presentations. 

Qualification:

• Substantial experience in managing China and International CDMOs for the manufacture of cGMP APIs and DP.
• Substantial experience with projects in clinical development e.g. Phase 1 through Phase 3 including multiple pharmaceutical dosage forms (e.g. tablets, capsules, topicals, etc.) .
• Experienced with cGMP manufacturing and IND and NDA filings; thorough knowledge of relevant NMPA and FDA regulations. 
• At least 10 years relevant experience in a pharmaceutical or biotechnology CMC/cGMP environment. 
• Experience in supply chain management .
• PhD or MS with 10+ years of experience; Advanced degree in Organic Chemistry or related scientific discipline is preferred. 
• Able to identify and resolve critical issues. 
• Experience implementing technical, strategic and operational plans. 
• Excellent written and verbal communication skills, exceptional interpersonal and management skills to collaborate with and direct the work of others on assigned projects (including both internal teams and external collaborators).