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Associate Director of Protein Analytical Sciences (Shanghai/Wuxi, China)

Key Accountibilities:

  • 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
  • Requirements:

  • 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.