上海招聘

Responsibilities

• Oversight of pre-formulation and formulation development for multiple oral dosage forms, drug substance and drug product process development. Lead process scale-up to enable project advancement from preclinical to clinical and from clinical to commercialization.
• Work closely with QC/QA, oversight, and coordination of CRO/CMO activities to ensure timely release of manufactured APIs and drug products.
• Oversees and manages clinical supplies to ensure timely supply of clinical investigational products and reference standards. 
• Ensure CMC development activities are appropriate at all stages of development.
• Collaborate with CMOs and CROs to ensure completion of project deliverables (materials, results, reports, etc.) and ensure regulatory compliance.
• Prepare, review, and/or approve study protocols, study reports, manufacturing batch records, development, campaign reports, and CMC regulatory submission document.
• Author and review pharmaceutical development reports, relevant sections of CMC documentations in support of INDs, IMPDs and NDAs submissions.
• Establish SOPs and workflows to ensure quality of API and drug product.  Assist in designing and continuously improving Quality Management System.  and find creative ways to resolve problems.
• Compiles and reports pharmaceutical development status to study teams and senior management.
• Assists with analytical method development and method validation. 
• Work effectively in cross-functional teams and support the team objectives in delivering project milestones.
• Minimum Qualifications
• Bachelor’s or master’s degree in in chemistry or related field.
• Experience in solid oral dosage formulation development, including capsules and tablets. Experience in analytical method development/validation or clinical trials supply chain management is a plus.
• Experience in small molecule drug pre-formulation characterization, formulation, and process development of oral dosage drug products
• Proficient in ICH and regulatory requirements. Knowledge in GMP and pharmacopeia/compendium requirements
• Willing to contribute and add value to company’s bottom line
• Travel (up to 20%) may be required, including international travel
• A minimum of 5 years’ pharmaceutical industry experience in pharmaceutical development and DS & DP related activities under cGMP environment
• Proficient in project and personnel management, excellent organizational skills, and the ability to work on multiple projects with a tight timeline
• Demonstrate troubleshooting and critical thinking skills.
• Highly productive, attention to detail, ability to manage time and prioritize tasks with input from manager to meet timelines.
• Interface with other functional groups within and outside CMC group to request/share information, provide results and coordinate testing.

徐诺药业是全美资公司，美国纳斯达克上市企业（Nasdaq:　XYN）。徐诺药业专注于同类最优肿瘤治疗方法，在全球授权引进、开发和商业销售抗肿瘤新药。领导团队由行业资深人士管理，世界一流的科学/医学顾问提供支持。与包括Pharmacyclics / AbbVie，Boehringer Ingelheim和Janssen的知名跨国药企合作。

徐诺药业目前的产品管线主要包括三款候选药物，艾贝司它、 XP-105 和 XP-102。公司拥有这些药物的全球独家开发、生产和商业化权益。其领先的候选药物艾贝司他正在进行治疗肾细胞癌（与培唑帕尼联用）和单药治疗非霍奇金淋巴瘤的全球关键3期临床试验。另外艾贝司他已获得2项美国FDA快速通道审评认定。徐诺药业另外一款临床阶段候选药物为可进入临床2期的XP-105（BI 860585），这是一个ATP竞争性的mTORC1 / 2抑制剂，对多种实体瘤有效。徐诺药业的临床前候选药物XP-102（BI 882370）是一个非常强效的，高选择性，非活性构象（DFG-out）泛-RAF抑制剂。徐诺药业还在近期会引进其他肿瘤产品。

公司创立团队曾在跨国生物制药公司（先灵、礼来、默克、罗氏、施贵宝）从事研发，临床，商务工作。


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