北京招聘

Position Summary:
With minimal direction, responsible for managing and supervising manufacturing production area. Responsibility includes maintaining production in full cGMP compliance. Supervise, hire, and develop staff and ensure production schedules are completed.

Key Activities and Responsibilities:
1. Compliance:
Manage the development and revision of SOPs.
Ensure cGMP compliance of operating areas.
Evaluate current operating procedures and recommend changes to management to optimize production. Assure all corporate change control procedures are followed, and Regulatory and QA are notified prior to the changes
Evaluate and approve reports and protocols
Ensure company policies are followed.
2. Process/Equipment/Facilities:
Ensure maintenance and validated status of systems.
Collaborate with cross-functional teams (i.e. QA/QC, PD, Regulatory, etc.) in completing production activities.
Develop, implement and assess solutions for complex problems.
Responsible for resolving problems during operation.
Oversees set up of critical new manufacturing processes.
3. Staff Supervision:
Responsible for selection, training, evaluation, staff relations and development of staff.
Ensure training programs are maintained.
Ensure scheduling of production and maintenance activities.
Interact with management in optimizing organizational structure and responsibilities.
Ensure plant safety through auditing and evaluations.
4. Other responsibilities that may be added, deleted, or changed at any time at the discretion of management, according to changes in regulations, will be informed, verbally or in writing.

Competences, Skills and Qualification:
1. Bachelor’s Degree in Life Sciences or Engineering or the equivalent combination of experience and education.
2. Typically 8+ years of related lab or manufacturing experience including 5 or more years of supervisory experience, and at least 1 year of cross-functional team leadership. Experience with a cGMP or other regulated environment.
3. Must have demonstrated/potential skills and competencies in the following areas:
？ Leadership and teambuilding
？ Conflict Resolution
？ Analytical Problem Solving
？ Project Management
？ Coaching, Mentoring and Counseling
？ Ability to be flexible and manage change
？ Excellent interpersonal and communications skills
？ Ethics and Integrity
？ Understanding of business needs
？ Ability to work across the organization and working with third parties to lead and/or support continuous Improvement programs to contribute to the maintenance of a strong cGMP compliance profile.
？ Demonstrate ability to create and manage work plans and timelines.
？ Knowledge of electronic data management system.

舒迪安是一家跨国的生物技术公司，致力于开发基于活化树突状细胞的新治疗方法，主要专注癌症和自体免疫性疾病的治疗。我们的使命是采用基于我们自有知识产权的细胞技术并通过我们自有的免疫疗法平台来开发新的治疗产品，为目前人类未得到满足的医疗需求提供世界前沿的拓展治疗手段。一大批世界知名科学家聚集在舒迪安公司总部位于布拉格的研究中心，他们借助于目前最尖端的实验设备积极探索树突状细胞在免疫反应活化治疗中的应用。

舒迪安公司通过下列方式开发最新治疗方法：
采用自体细胞免疫疗法治疗癌症和自体免疫疾病
采用免疫疗法配合化疗等其他标准治疗方式提高临床疗效
研究免疫疗法的长期治疗效果以增强免疫系统对特定疾病的反应能力
使用广谱的肿瘤抗原，通过患者自身树突状细胞的活化，来刺激复杂的免疫反应

舒迪安公司的临床开发方案旨在采用活化树突状细胞免疫疗法，其自体细胞肿瘤免疫治疗产品为某些特定的、现有治疗手段匮乏的部分疾病拓展治疗选择。舒迪安在欧洲和中国北京建设了GMP标准细胞实验室，所生产的基于细胞的医疗产品均符合全球监管标准。

针对不同的癌症（前列腺癌、肺癌、卵巢癌等），舒迪安公司正在开展基于成熟树突状细胞负载免疫原性死亡肿瘤细胞技术的肿瘤免疫疗法的临床应用。多个单病种癌症的临床试验结果验证了舒迪安产品的临床安全性和有效性，显示出了令人振奋的临床治疗效果。

公司地址：北京亦庄经济开发区科创14街汇龙森科技园30号楼B座
市内办公室: 北京朝阳区亮马桥路50号燕莎写字楼C214

Company Introduction
SOTIO is a European biotechnology company developing new therapies based on activated dendritic cells, focusing on the treatment of cancer and autoimmune diseases. Our mission is to develop new medical therapies using our proprietary cell-based technologies to treat highly unmet medical conditions using our immunotherapy platform. Sotio (Beijing), a fast growing subsidiary focusing on China market, is looking for talented, motivated, dynamic employees to join its international team. The company can provide tremendous career development opportunity to its employees.

SOTIO is an Equal Employment Opportunity/Affirmative Action Employer
The policy and practice of SOTIO require that entry into employment and progression within employment will be determined only by personal merit and the application of criteria which are related to the duties of each particular job. Subject to statutory provisions, no applicant or member of staff will be treated less favorably than another because of his or her gender, marital or civil partnership status, sexual orientation, religion or belief, racial group, age or disability. In all cases, ability to perform the job will be the primary consideration.