大家好,某知名制药企业由于发展,寻求Director in Pharmaceutical Sciences -Process Chemistry Development,工作地点上海。
要求: PH.D学历,在化学合成生产工艺有丰富的经验,最好有海外背景。
Job Responsibilities:
Manage chemical process research/development and API (Active Pharmaceutical Ingredient) manufacturing for preclinical and clinical projects.
• Manage the process chemistry interface with medicinal chemistry group in drug discovery.
• Design and develop chemical processes at scales from grams to kilograms for preclinical and clinical compounds.
• Manage technology transfer for large scale manufacture of API.
• Manage a scientific staff.
• Write technical reports and prepare regulatory submission documents.
• Select, qualify and manage external vendors for drug substance manufacture.
• Assist in project portfolio and talent development within Pharmaceutical Sciences.
• Build internal capability for API manufacturing at kilogram scales.
Qualifications:
• PhD in chemistry or equivalent with 10 years of industrial experience focusing on chemical process research and development and scale up.
• Extensive experience of large scale manufacturing of API under GMP.
• Strong ability to manage technical staff.
• Demonstrated organizational and project planning skills.
• Familiar with the pharmaceutical development process and regulatory submission requirements for the Chemistry, Manufacture and Control (CMC) sections in China.
• Proficiency in written and spoken English desirable.
• Good interpersonal and communication skills.
• Highly motivated and good team player.