職位描述
職位描述：
Group leader, Cell Culture, Process Sciences
Overview:
Group leader position is available within Cell Culture group in Process Sciences Department at ChemPartner in Shanghai. The group is responsible for developing and supporting cell culture manufacturing process for early phase clinical programs. We strive for speedy delivery of high quality processes that are high yield with desirable product qualities, manufacturing friendly, and robust. The group interacts closely with Cell Line Development, Pilot Lab, Purification, and Protein Analytics within the department, and Manufacturing, Quality, CMC, and Discovery etc. outside the department. We are seeking an enthusiastic, creative scientist who will make tangible contribution to the continuous improvement and innovation within the organization.
Key responsibilities:
? Initiates, manages and provides scientific feedback on process development and continuous improvement, with the expectation that the ideas demonstrate a high level of scientific initiative and provide the strategic perspective
? Serves as a technical resource, leader and mentor for project teams
? Oversees tech transfers to manufacturing
? Leads team in troubleshooting and investigation activities
? Consults on and authors components of regulatory filings
? Integrates knowledge base across multiple disciplines and applies within regulatory constraints
? Acts as subject matter expert with Regulatory agencies
? Establishes best practices and makes recommendations
? Influences areas outside of own discipline
? Builds and leverages upon collaborative relationships throughout the organization
? Provides analysis and advice to senior department management.
? Presents original work internally across departments and divisions, and at external conferences
? May author or co-author peer-reviewed scientific papers or patents
? Supervise 5 direct reports
Qualifications
? PhD/MS degree in chemical engineering or biochemical engineering or related disciplines
? 2 to 8 year's of experience in cell culture process development or manufacturing support
? Broad experience across range of manufacturing process life cycle phases preferred
? Basic knowledge in related functional areas, such as purification, protein analytics, CMC, and regulatory, desirable
? Strong interests and experience in bioreactor control preferred
? Advanced experience in knowledge management systems preferred
? Candidate must be a goal oriented team player with excellent communication skills
