细胞培养开发经理

职位描述

Principal Duties and Responsibilities Supervise personnel/resources for manufacturing of Bulk Active Pharmaceutical Ingredients(API) regulated by the Food and Drug Administration(FDA) according to current Good Manufacturing Practices(cGMP) to accomplish all department goals and objectives while operating in a safe manner and in compliance with all applicable regulations Execute and evaluate laboratory-scale cell culture experiments in order to develop robust processes suitable for GMP clinical and commercial manufacturing Make use of sound statistical DOE-based cell culture experiments in order to develop robust processes suitable for GMP clinical and commercial manufacturing. Write and revise protocols, procedures, reports, batch record and other process related documentation as necessary to support GMP manufacturing operations. Ensure tasks are completed in accordance with approved site procedures, batch records, and protocols. Maintain necessary process development documentation standards including process development reports, technical transfer reports, and characterization and validation protocols and electronic data histories. Develop employee’s knowledge, understanding, and skills to improve performance and expand abilities. Completes, reviews, and corrects critical documentation including SOP Forms, Batch Records. Logbooks to ensure completeness and accuracy in compliance with all applicable procedures and ensure completeness and accuracy in compliance with all applicable procedures and ensuring quality documentation under good manufacturing and documentation practices. Ensure employees remain current with all department and site training requirement. Taking an active role in incident inquiry, investigation, and reporting. Understanding all manufacturing systems within the production space, including knowledge of ancillary equipment such as storage and distribution systems, waste neutralization systems, heating/cooling units, vacuum units, etc. Communicate the group’s status, data and feedback to management. Other tasks as needed by the company. Job Requirements MS in Chemical/Biochemical Engineering, Biochemistry, Cell Biology, or related discipline with 2-5 years of experience focused on mammalian cell culture process development for the production of therapeutic proteins Excellent oral and written communication skills in English and Mandarin(Read, Write, Verbal) demonstrated by communicating with other functions and management regarding resolving investigations and theory.  Familiarity with laboratory procedures and operations including set up and operating shake flasks , lab scale bioreactors and pilot scale disposable bioreactors and associated analytical equipment used for mammalian cell culture processes. Experience with scale up, medium selection and process optimization. Experience with authoring IND, CTA, and BLA regulatory documents. Understanding of the application of GMP in the development and production process. Capable of writing details reports and summaries and exhibit detail oriented documentation skills. Capable of writing detailed reports and summaries and exhibit detail oriented documentation skills. Communicate effectively and work professionally in a team environment Highly skilled in Word, Excel, and PowerPoint; experience with statistical DOE software