必备条件:
有丰富的生化实验室
熟悉生化验证
单抗或肿瘤背景优先
有带人和管理经验
英语完全作为工作语言
优先条件:
一线外资工厂生化实验经理或主管岗位
岗位职责:
1. Quality Control Management:
- Extend QC lab and build its analytical capability for entrusted product (biologics) release testing covering from raw materials, excipients, intermediates (API), and finished goods leveraging current QC capabilities.
- Supervise and coordinate quality control activities for CMO (biologics) production.
- Implement, and maintain quality control procedures and protocols.
- Ensure compliance with GMP, company policies, and regulatory requirements.
2. Team Leadership:
- Manage, train, and mentor quality control team members.
- Assign tasks, monitor performance, and provide feedback to team members.
- Foster a culture of continuous improvement and quality excellence.
3. Technical Expertise:
- Oversee and perform complex analytical testing of biologics (e.g. bioassay and function testing, Glycosylation analysis, physicochemical characterization …, etc).
- Interpret test results and make decisions on product quality and release.
- Troubleshoot and resolve quality-related issues in the production process.
4. Documentation and Reporting:
- Ensure accurate and timely documentation of all quality control activities.
- Prepare and review batch records, test results, and quality reports.
- Maintain up-to-date standard operating procedures (SOPs) for quality control processes.
5. Regulatory Compliance:
- Stay informed about relevant regulations and guidelines in the biopharmaceutical industry.
- Participate in regulatory inspections and audits.
- Contribute to the preparation of regulatory submissions related to quality control.
6. Continuous Improvement:
- Identify opportunities for process improvements and cost reductions.
- Implement new technologies and methodologies to enhance quality control efficiency.
- Collaborate with other departments to optimize production and quality processes.…
任职要求:
• Experience:
工作经验:
- Minimum of 5 years of experience in quality control within the biopharmaceutical industry, with at least 2 years in a supervisory role.
- In-depth knowledge of GMP regulations and quality control processes for biologics .
- Proficiency in quality management systems and relevant software applications.
• Soft skill:
通用技能:
- Strong analytical and problem-solving skills.
- Excellent leadership and communication abilities.
• Technical skill:
专业技能:
- Proficiency in using HPLC (RP-HPLC, IEX,SEC, …, etc )for identity, purity, impurities of biologics
- Expertise in Capillary Electrophoresis (CE) molecular variants and impurities.
- Expertise in Cell-Based Assays and functions testing of biologics.
- Expertise in data Analysis and Interpretation, i.e. Statistical Analysis of QC data to identify trends and deviations and using QC software and data analysis tools effectively.
• Education:
教育背景:
- Bachelor's degree in Biochemistry, Biotechnology, Pharmaceutical Sciences, or a related field. Advanced degree (MS or PhD) preferred.
• Languages:
语言要求:
Proficiency in English, oral and written
• Play to Win Behaviors: Stretch; Take Action; Act for Patients & Customers; Think One Sanofi
全力致胜行为: 超越自我, 主动出击, 以患者和客户为本, 团结一致