长沙招聘

职位描述：
工作地点：上海
1. Work closely with line manager to meet project timelines, departmental goal, and customer requests.
2. Work with line manager to roll out QbD related training modules, tools and methodology, develop and implement QbD processes for all projects, thus developing “right first time” approach for customers.
3. Provide technical oversight and leadership during formulation and process development, scale up and post approval process optimization.
4. Lead scale up, technical transfer (site to site or PDS to site) and support product control strategy translation to shop floor, making sure developed manufacturing process and PCS are capable of continuously manufacturing high quality drug product at commercial manufacturing site.
5. Independently design experiments and conduct drug product development work with an awareness of state-of-the-art technology to support formulation and process development of drug product. Generate development plans, summaries and reports as needed.
6. Participate in teleconferences and review update reports on ongoing projects to keep customers briefed on progress of projects.
7. Work with line manager to provide technical leadership for the rapid resolution of technical issues during process development, scale up, technical transfer and post approval commercial manufacturing.
8. Mentor and coach junior scientists in designing and implementing innovative solutions for assigned activities.
Qualification :
MS or Ph.D. degree in pharmaceutics or other directly-related discipline with 5+ years experience or training in formulation development as well as clinical product manufacturing.
Candidates with extensive experience in QbD based drug product development and project management are desired.
Modern pharmaceutics theory esp. industrial pharmaceutics.
Extensive knowledge and understanding in QbD.
Extensive knowledge and experience in pharmaceutical development processes from preformulation to commercial manufacturing.
Rich experience in formulaton and process development, process scale up, trouble shooting and process optimization of oral solid and liquid dosage form.
Well proven technical, project and matrix leadership to lead and deliver complex PD projects.
Know-how and expertise in unit operations (eg. Wurster suspension/solution layering, powder layering, hot melt layering, extrusion-spheronization, hot melt extrusion, coating, granulation, tablet compression) for oral solid dosage form and liquid dosage form).
Capabilities of working across different scientific disciplines and integrating knowledge from a variety of sources.
Bilingual: excellent written and oral communication skills in Mandarin and English.
Skilled computer capabilities.
Excellent presentation skills, creative thinking, good team player, plan and do the work independently.
Good interpersonal and cross functions communication skills.
Strong problem solving skills and focus on details, execution and delivery.
Capability of fast learning and open minded to new initiatives. 举报 分享

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