Head of Microbiology Lab, Biologics 25-30k·13薪
上海-浦东新区 10年以上 统招本科 招1人 8月12日更新
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Talent Acquisition Partner · 罗氏中国
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职位介绍
在罗氏,我们鼓励每位同事展现真实的自己;我们欣赏独特且出众的品质。罗氏的文化鼓励积极的表达、开放的对话和真诚的连结,在这里,你将因为做自己而被重视、接纳和尊重,并得到个人的提升和职业的发展。所有的这一切,都是为了更好地预防、阻止和治愈疾病,并确保医疗资源的可及性和可持续性。欢迎加入罗氏,一个重视每种声音的地方。 职位 Engineering Project Support and Operation Readiness: ● CCS Support: Support the establishment of the Contamination Control Strategy (CCS) for the aseptic production line. ● Environmental Monitoring (EM): Support EMPQ and establish risk based environmental monitoring strategy and ensure its effective implementation. ● Microbiology Method Validation: Responsible for the validation of microbiology methods, including supporting the confirmation of cleaning and disinfection processes, and the efficacy of disinfectants. ● Lab Setup: Lead the setup of a microbiology laboratory that complies with regulatory requirements and build a BSL-II (Biosafety Level 2) lab management system. ● Equipment Support: Support the Performance Qualification (PQ) of laboratory equipment and ensure routine operation. Routine Operation: ● Compliance Leadership: Lead the execution and oversight of environmental monitoring and critical facility testing in accordance with Chinese GMP, EU GMP, U.S. cGMP regulations, and Roche/Genentech standards. ● Methodology Management: Lead the continuous effort to ensure all microbiological test methods are validated and that their validation status is maintained as effective. ● Audit Readiness: Be accountable for audit readiness by ensuring compliance with effective standards and regulatory/statutory guidelines. Actively lead the team's response to regulatory inspections and global quality audits. ● CCS and Training: Drive the continuous support of the effectiveness of the Contamination Control Strategy (CCS) and lead the organization of microbiology-related training. ● Product Release Leadership: Be accountable for product release testing, ensuring timely delivery according to lead time requirements and guaranteeing compliance with Data Integrity (DI) standards. ● Team Development: Lead the development of a competent team through coaching, mentoring, and training by having a skills competencies development and appraisal program in place to strengthen the technical expertise and capabilities. Qualification and Experience Education/Qualifications ● Bachelor’s Degree (Life Sciences, Microbiology, or Analytical Sciences is preferred) and above ● Special Equipment management certification Leadership Competencies ● Take a genuine interest in people ● Listen carefully, tell the truth, and explain the why ● Empower and trust people to make decisions ● Discover and develop the potential in people ● Strive for excellence and extraordinary results ● Set priorities and simplify work ● Congratulate people for a job well done Job Required Competencies ● 5 or more years of QC experience, QC experience, with a focus on microbiology and aseptic processes. MNC Bio-pharma experience is preferred ● 3 or more years of People management experience ● In-depth knowledge of quality control procedures and legal standards, with extensive experience in aseptic assurance and microbiological testing. Possess hands-on experience in Contamination Control Strategies (CCS) and Environmental Monitoring (EM) control strategies. ● Advanced knowledge of regulatory requirements in the industry. Experience with compliance inspection by NMPA/FDA/EMA/TGA/PMDA. ● Experienced in strategic project of QC design, commissioning & qualification. Experienced in QC new facility startup readiness and operation ramp up including organization, people and operation management system. ● Able to think strategically and translate strategies into actionable plans, understands and applies agile ways of working ● Fluent communications skills in English and the ability to effectively communicate, collaborate, and foster positive interactions with team members and stakeholders. 我们是谁 打造更健康的未来是促使我们创新的动力。全球超过100,000名员工共同致力于推进科学,确保今天和明天的人们,都能获得高质量的医疗资源。我们的努力帮助了2600多万人使用我们的药物进行治疗,我们的诊断产品运行超过300亿次检测。罗氏通过赋能探索新的可能、激发创造力并保持高标准以提供突破传统的医疗解决方案,对全球的医疗环境带去推动和影响。 让我们一起,构建更健康的未来。 罗氏提供平等的职业发展机会。
其他信息
行业要求:制药

公司简介

罗氏成立于1896年,总部位于瑞士巴塞尔,拥有125余年悠久历史。罗氏致力于不断探索从前沿科学到疾病诊断和治疗药物的成果转化,挽救生命、改善人类生活质量,在抗肿瘤、免疫、抗感染、眼科和神经科学领域拥有差异化药物。 作为个体化医疗的倡导者,罗氏不遗余力地推进医疗健康发展,以期创造更大价值。凭借制药和诊断两大领域的独特优势,结合临床实践中的数据洞察,罗氏积极携手合作伙伴,致力于为每位患者提供合适的治疗方案。 罗氏总部位于瑞士巴塞尔,业务遍及全球150多个国家。罗氏连续15年位列道琼斯指数(DJSI)制药、生物技术和生命科学领域可持续发展的全球先行者之一。这是对罗氏携手全球合作伙伴,为提升医疗健康可及性长期贡献的高度认可。 美国基因泰克公司(Genentech)是罗氏集团的全资子公司。此外,罗氏也是日本中外制药株式会社(Chugai)的控股方。 更多关于罗氏集团的信息,请登陆罗氏全球网站 www.roche.com。
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更新时间:2026-08-15