Associate Director of Protein Analytical Sciences (Shanghai/Wuxi, China)
Lead analytical group for biologics service at Shanghai and interact with Biologics sites at Wuxi and Philadelphia
Develop and improve analytical platforms for biologics to meet increasing demands of clients
Provide technical oversight (guidance) to staff in the Protein Analytical Sciences groups. Ensure ongoing training programs for continuous growth of key personnel. Recruit, train and retain a high performance team to ensure best quality services.
Provide technical leadership for all aspect of analytical services for a broad portfolio of biologics (mabs, ADCs, therapeutic proteins)
Contribute to growth of biologics business by using existing contacts and establishing contacts with new customers.
Build new capabilities and enhance current service offering of bioanalytical service and develop new clients by building up team and by evaluating new technologies/ equipment which can bring value to the customers
Contribute to budgeting process of Biologics Development and ability to operate within budget by maximizing efficiencies and pioneering innovative techniques
Work closely with Biologics Development department head to meet project timelines, departmental goal, and customer request.
Coordinate with the customer for new projects, preparing technical proposals addressing their needs and drawing up cost estimates for project work. Coordinate with customer service on project proposals for customers.
Participate in telecons, prepare update reports on ongoing projects to keep customers briefed on progress of projects , also prepare and review final reports for closing of projects
MS or Ph.D. degree in a relevant biopharmaceutical science discipline with 15+ years of industrial experience in the fields of biologics analytical release and characterization assay development, qualification, validation and transfer
Demonstrated record of accomplishments and in depth technical experience in the biologics analytical assay development intended for clinical trials and commercialization. Must be able to work in a team-oriented manner in order to accomplish objectives.
Must be proficient with the requirements of the FDA/EMA cGMP regulations, ICH guidelines. Familiarity and understanding of the CFDA cGMP regulations preferred.
Excellent written and verbal communication, negotiation, problem solving and decision making skills, and outstanding interpersonal skills
Demonstrated leadership and capability for strategic analysis and conflict resolution, organizational and project management skills preferred.