上海招聘

职位描述：
1. Work closely with line manager to meet project timelines, departmental goal, and customer requests.
2. Work independently or as a team member to provide technical leadership and expertise during development of solid, solution, suspension, gel, cream, etc.
3. Apply QbD related mindset and methodology into formulation and process development, scale up and post approval process optimization for all projects.
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. 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.
7. Mentor and coach junior scientists in designing and implementing innovative solutions for assigned activities.
8. Work with PDS cross functions to plan and implement technical capabilities upgrades and improvement by rolling out OSD training modules and establishing new technology platform, which can bring value to the customers.

Pharmaceutics or other directly-related discipline with 6+ years experience or training in formulation development as well as clinical product manufacturing.
Candidates with extensive experience in process development, process scale up, trouble shooting and process optimization of oral solid dosage form are desired.
Modern pharmaceutics theory esp. industrial pharmaceutics.
Extensive experience in process development, process scale up, trouble shooting and process optimization of oral solid dosage form.
Familiar with development process of new and generic drug product and relative regulations.
Know-how and expertise in lab scale, pilot scale and production scale pharmaceutical equipment for oral solid dosage form.
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).
Potential of working across different scientific disciplines and integrating knowledge from a variety of sources.
Bilingual: good written and oral communication skills in Mandarin and English.
Skilled computer capabilities.
Good 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

合全药业是在中美两地均有运营的药明康德子公司，服务于生命科学行业，拥有卓越的化学创新药研发和生产的能力和技术平台。作为全球新药合作研究开发生产领域（CDMO）的领军企业，合全药业致力于为全球合作伙伴提供从原料药（API）到制剂，高效、灵活、高质量的一站式解决方案。

合全金山工厂占地14英亩，是cGMP的生产基地，金山工厂能够生产从公斤级到吨级的产品，包含一个公斤级实验室、两个中试车间和一个商业化车间，反应釜体积从5 L至20,000 L，还包含一个cGMP的高活性原料药生产设施、质量控制实验室、仓库和溶剂罐区。

合全金山工厂分别于2013、2014、2016年和2018年四次通过美国FDA检查，得到8个国际监管机构批准，可为美国、欧洲、日本、加拿大、瑞士、澳大利亚、新西兰和中国的生产商业化创新原料药（APIs）
金山工厂配备有先进的生产设备，具有经验丰富的技术人员，可生产多种反应类型的产品，如不对称催化氢化、对空气和水敏感的金属催化、高温、高压、低温和氧化反应。此外，还可使用高技术生产工艺，如高体积液氮、连续化工艺（流体化学）和生物催化。

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