職位描述
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. 工作職責(zé)：1.負(fù)責(zé)管理和協(xié)調(diào)穩(wěn)定的活性藥物成分和cGMP的藥物產(chǎn)品環(huán)境。 2.負(fù)責(zé)所有客戶的實(shí)驗(yàn)室，進(jìn)行分析，提供穩(wěn)定的中期報告。 3.管理和協(xié)調(diào)所有穩(wěn)定性程序。4.編寫新的SOP和實(shí)施員工培訓(xùn)計劃。5.在實(shí)驗(yàn)室系統(tǒng)和儀表維修提供技術(shù)性支持。 任職資格：藥物化學(xué)碩士（博士優(yōu)先）。5年以上的相關(guān)工作經(jīng)驗(yàn)。 職位概覽 為配合公司實(shí)驗(yàn)室建設(shè)及開展檢測業(yè)務(wù)，杭州艾品公司特此招聘以下各個部門的各類層次人員 (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：成功應(yīng)聘者將由杭州艾品公司直接聘用并提供薪酬及福利待遇。所有雇員與長三角綠色制藥協(xié)同創(chuàng)新中心或其協(xié)同成立單位（包括浙江工業(yè)大學(xué)）將無任何形式的勞務(wù)關(guān)系。聯(lián)系方式 Contact Info： 人事經(jīng)理 hr@irvinepharma-china.com 請按照下列格式書寫email主題：申請部門_職位_最高學(xué)歷_姓名。舉例，一位叫張三的申請者，最高學(xué)歷是碩士（MS），申請分析部門(Analytical Chemistry) 的HPLC Supervisor職位，則主題格式為：Analytical Chemistry_HPLC Supervisor_MS_Zhang San。同時，請按照同樣規(guī)則將所附簡歷命名。即其簡歷命名為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.
