上海招聘

Responsibilities

● Responsible for analytical method development, specification setting, release testing, stability studies, and method validations to enable project advancement from discovery to commercialization.

● Support science-driven, phase appropriate, and risk-based analytical development to support preclinical and clinical programs from discovery, first-in-man to commercial registration at contract sites.

● Critically review data from contract partners, provide timely feedback to secure prompt resolution of technical and quality findings.

● Work effectively in cross-functional teams and support the team objectives in delivering project milestones.

● Work closely with contract partners to ensure timely release testing and stability programs of Xynomic’s development programs.

● Author and review analytical reports, relevant section of CMC documentations in support of INDs, IMPDs and NDAs submissions and their amendments.

● Serve as the analytical lead for Xynomic, assess capabilities and processes, and take initiative in promoting best practices for continuous improvement.

● Establish analytical labs, SOPs and work flows and find creative ways to resolve problems.

● Compiles and reports analytical development status to study teams and senior management

Minimum Qualifications

● Master or Ph.D. Degree

● 5+ years’ experience in analytical method development for small organic molecules, small molecule drug substance and drug product

● Experience in different analytical method, such as HPLC/UPLC, LC-MS, GC, dissolution, IR, XRPD, PSA/PSD, DVS, DSC, TGA and etc. Experience in these method development and method qualifications and/or validation.

● Knowledge in ICH and regulatory (GLP and GMP) requirements for analytical method development and validation.

● Proficient in pharmacopeia/compendium requirements for different test methods and their qualifications.

● Willing to contribute and add value to company’s bottom line

● Travel (up to 10%) may be required, including international travel

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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