主要职责:
• Direct the manufacturing operations of cell culture, downstream processing, and fill finish in a multiple product facility.
• Allocate resources to achieve ****ives and ensure the production schedules are met.
• Ensure critical manufacturing documentation are prepared timely such as BOM’s, BR’s, SOP’s and specifications.
• Oversee raw material inventory, GMP cleaning and gowning management to ensure compliance with current Good Manufacturing Practices (cGMP), policies and safety practice.
• Provide technical expertise for manufacturing deviations, OOS/OOT investigations by working in concert with Quality Assurance to ensure proper disposition of affected materials.
• Support operational budgets, cost controls and resource planning to meet corporate strategic ****ives.
• Developing staff capabilities, creating a culture of safety, maintain training ****ives, compliance and collaboration while implementing process improvements where applicable.
任职要求:
• Advanced degree in a scientific discipline (i.e. Chemistry, Microbiology, Chemical Engineering).
• More than 10 years’ biotech manufacturing/development environment experience and more than 5 years’ experience in supervising position.
• In-depth knowledge in drug substance and/or drug product manufacturing and engineering aspects of larger scale operations.
• Hands on GMP experience with all phases of drug development, as well as in-depth knowledge and full understanding of GMP requirements.
• Strong leadership and excellent verbal & written communication skills
目前已发展成为集化学、生物药物研究,医药中间体、原料药合成,制剂制造和产品销售于一体的创新型医药集团,是国家最早评定的重点高新技术企业、中国制药工业百强企业之一,国内最大的抗肿瘤和精神类药物研发和和生产基地之一。
依托优异的产品品质、专业化的营销服务,公司的品牌价值不断提升,市场规模不断扩大。目前,公司在抗肿瘤、精神、糖尿病、消化道及抗生素等五大领域有20多个品种进入市场销售。抗肿瘤药物,精神类药物,糖尿病药物,消化道药物等品种,市场份额居同品类前列。