居住国家 美国
居住城市 Irvine, California
功能区域 Research & Development
工作组 Analytics
雇佣类型 长期合约
工作时间 全职
In this strategically important role, you are part of the Site Leadership Team. It's critical for the success of the site, as your team is involved in each process. Join our growing company and our site in Irvine in a high visibility high impact role!
在我们公司工作
• Medical – HMO, PPO & HSA Plans
• Dental – HMO & PPO with or without Orthodontia
• Vision
• FSA – Medical & Dependent Care
• Employer Sponsored Life Insurance, Short- & Long-Term Disability
• Voluntary – Life, Accident, Critical Care & Hospital Indemnity
• Pet Insurance Plan
• 401(K) Plan
• Generous PTO, Sick and Holiday Time Off Structure
我们是谁
在人们的生活中–全球 齐格菲集团（Siegfried Group）是全球领先的定制开发和制造组织（CDMO）之一，致力于开发和生产活性药物成分（API），中间体和最终剂型。作为我们的核心竞争力，我们成功地将化学和制药能力整合到一个商业模式中。 齐格菲（Siegfried）这个名字代表着最高的质量，效率，灵活性和安全性。我们的业务遍及欧洲，亚洲和北美，从主要的国际制药公司到小型生物制药组织，为广泛的全球客户群提供服务。我们为他们开发和生产大规模的产品创新产品到成品。我们将报价无缝整合到客户的价值链中。我们的综合服务范围涵盖从早期研究与开发服务（例如合成，放大，配方开发，稳定性研究和方法开发）一直到制造服务，从用于临床试验目的的临床前研发材料到商业生产。 我们能够生产约1500种注册药物中的约200种。此外，我们生产的咖啡因占全球需求量的20％。因此，将近10亿个人与Siegfried产品接触。
我们在做什么Irvine
Irvine is one of Siegfried’s sterile drug product manufacturing sites, providing contract development and manufacturing services (CDMO) specializing in difficult to manufacture pharmaceuticals, ophthalmics, and drug delivery devices.
Main activities
- Provides cGMP sterile drug product fill finish of biologics, suspensions, emulsions, ointments, and gels
- All fully cGMP and SHE compliant
Features
- Commercial Products: 5 automated filling lines, Commercial manufacturing, Batch sizes up to 150 K units, Fill Volumes 0.5 ml – 100 ml
- Semi-automated and automated visual inspection
- Automated packaging with digital data visual verification
- Stability study services
- Drug delivery
- Laboratory services
- Clinical Products small lot capability (semi-automated filling, batch sizes up to 5 K units)
- Clinical manufacturing (batch sizes less than 5 K units)
Strategic importance
- CDMO for innovative and difficult-to-manufacture products from clinical to commercial NDA and ANDA products
- Provides contract sterile drug product manufacturing and laboratory services to the pharmaceutical and biotechnology industries