上市公司招聘新药工艺和分析总监或副总裁
公司背景:
香港上市创新药企,小分子肿瘤领域的管线为主
下属团队:
10人左右
Head of Analytical
Key Objectives:
1.Responsible for analytical aspects of drug substance/product development, including analytical method development, validation and implementation, specification establishment, technology transfer, aberrant investigation, etc.
2.Collaborates closely with Discovery, Process, Formulation, QA, Regulatory, ESH and other functions
3.Leads and manages an experienced team of analytical chemists
4.Authors, reviews, and approves technical reports and regulatory documents
5.Effectively guides and manages external collaborations
Requirements:
1.PhD in analytical chemistry or related discipline with 8+ years of pharmaceutical industry experience
2.Experienced in analytical method development and validation
3.Proven skills in analytical method and instrumentation problem solving
4.Knowledgeable in cGMP, USP, ICH relevant guidelines
Head of Process Chemistry
Key Objectives:
1.Responsible for drug substance development, including chemical process development and optimization, process performance qualification and validation, technology transfer, GMP production, etc.
2.Collaborates closely with Discovery, Analytical, Formulation, QA, Regulatory, ESH and other functions
3.Leads and manages an experienced team of process chemists
4.Authors, reviews, and approves technical reports and regulatory documents
5.Effectively guides and manages external collaborations
Requirements:
1.PhD in synthetic organic chemistry with 8+ years of process chemistry industry experience
2.Proven track-record of achievements
3.Experienced in process development and optimization
4.Knowledgeable in GMP relevant guidelines