职位描述
Responsible for managing and coordinating stability activities of Active Pharmaceutical Ingredient (API) and drug products in cGMP environment. The activities include coordinating sample submission, monitoring stability chambers and preparing documentations such as protocols and reports. The candidate will also be responsible for interacting with all LAB clients, sample receipt, method transfer, project initiation, sample analysis, and providing stability interim reports to our clients. Will manage and coordinate all stability programs. Communicate with LAB clients to design and prepare stability protocols. Collaborate with Customer Services, Quality Control; Quality Assurance; Research and Development functions to ensure all stability programs are being initiated and conducted according to approved protocols. Will monitor all stability programs. Will work closely with Business Development to provide support to LAB clients. Perform statistical analysis and trending of stability data. Coordinate qualification and validation of stability chambers, software and equipment used for stability programs. Supervise stability personnel. Write new SOPs and Implement training programs for staff. Responsible for initiating OOS investigations when required. Provide technical support in the maintenance of lab systems and instrumentation. Ensure that all jobs are completed on time. Responsible for significantly contributing to the conceptualization and development of new procedures, systems, and techniques. Must have extensive experience in managing various stability programs with strong understanding and knowledge of ICH guidelines and FDA stability requirements. This job also requires attention to details and strong time management skills. Must demonstrate skills and past experience in managing multiple projects/programs and/or handles multi-disciplinary aspects of projects. Must be familiar with interpretation of stability data and projecting use-time and expiration date. Exceptional communication and leadership skills and the ability to work effectively in multi-disciplinary team environment are must prerequisite for this position. Experience with various modes of HPLC, pharmaceutical analysis, analytical method development and validation for small molecules as well as proteins and peptides is highly desirable. Must have a winning attitude and business mindset demonstrated by a "can do" approach to issues, resilience, commitment to goals, and persistence. Work with departmental leadership to meet project goals of planning, organizing and delivering effective, on-time. Requires a MS degree (Prefer Ph.D.) in Pharmaceutical Chemistry, or in equivalent scientific field with a minimum of 5 years of relevant experience. Previous stability department supervisory experience is required. Must demonstrate proficiency with the preparation of regulatory submissions, ability to manage multiple projects and meet critical deadlines. Must demonstrate successful interdisciplinary collaboration in a team setting. Communicate (verbal and written) information in a timely manner to clients and department supervisor. Demonstrated successful interdisciplinary collaboration in a team setting. This position requires the ability to manage the stability department. 工作职责：1.负责管理和协调稳定的活性药物成分和cGMP的药物产品环境。 2.负责所有客户的实验室，进行分析，提供稳定的中期报告。 3.管理和协调所有稳定性程序。4.编写新的SOP和实施员工培训计划。5.在实验室系统和仪表维修提供技术性支持。 任职资格：药物化学硕士（博士优先）。5年以上的相关工作经验。 职位概览 为配合公司实验室建设及开展检测业务，杭州艾品公司特此招聘以下各个部门的各类层次人员 (Technician, Associate, Supervisor, and/or Managers): Analytical Chemistry; Analytical Development; Stability; Biopharma; Microbiology; Quality Assurance; Business Development & Marketing; Finance; Human Resources; MIS; ICVS; Corporate Planning & Scheduling; Purchasing & Facilities;注意：成功应聘者将由杭州艾品公司直接聘用并提供薪酬及福利待遇。所有雇员与长三角绿色制药协同创新中心或其协同成立单位（包括浙江工业大学）将无任何形式的劳务关系。联系方式 Contact Info： 人事经理 hr@irvinepharma-china.com 请按照下列格式书写email主题：申请部门_职位_最高学历_姓名。举例，一位叫张三的申请者，最高学历是硕士（MS），申请分析部门(Analytical Chemistry) 的HPLC Supervisor职位，则主题格式为：Analytical Chemistry_HPLC Supervisor_MS_Zhang San。同时，请按照同样规则将所附简历命名。即其简历命名为Analytical Chemistry_HPLC Supervisor_MS_Zhang San.If using email to forward resume, please follow the renaming rules below: Department_Position_Highest degree achieved_Last name First name. For example, an applicant named Zhang San wants to apply for the position of HPLC Supervisor in the department of Analytical Chemistry. The highest degree he had is M.S. Then please write email subject as Analytical Chemistry_HPLC Supervisor_MS_Zhang San. On the other hand, please rename the resume to Analytical Chemistry_HPLC Supervisor_MS_Zhang San as well.
