Director/Senior Director, Downstream Development
Description
Downstream Process Development Wuxi subdivision is responsible for purification process development, scale-up, technology transfer, process characterization, new technology development, and supports for pre-clinical, clinical, and commercial manufacturing, IND and BLA filing and PPQ execution.
The Director/ Senior Director leads and guides a downstream development sub-team, which includes technicians, scientists, senior scientists, group leaders, assistant/associate directors. Manage timelines and resources to develop scalable and robust protein purification processes for pre-clinical, clinical and commercial manufacturing, to execute downstream process characterization, and to support process validation and manufacturing.
Responsibilities:
- People management, training, and development to ensure his/her team perform well in a fast-paced environment.
- Execute and/or oversee downstream process development, scale-up, technology transfer, and process characterization.
- Design the downstream processes that are efficient, robust and scalable for clinical and commercial manufacturing.
- Advance downstream processes to ensure our competitive edge in the field and develop intellectual properties and patents.
- Support the preparation of dossiers and data packages to assist IND/BLA filing.
- Assist the functional head to coordinate the works between the downstream development group and other functional groups to meet department goals.
- Interface with other internal teams and clients effectivelly
· Guide risk assessment and mitigation strategy development.
Basic Qualifications:
- MS with 12+ years, or PhD with 7+ years downstream process development experience.
- At least 4 years’ people management experience and having strong management and leadership skills.
- Good communication skills (verbal and written) in Chinese and English.
- Extensive experiences in both early-stage and late-stage Downstream process development.
- Skilled in Design of Experiments.
- Have a good deep understanding of the limitations of manufacturing when designing and scaling up purification processes.
- Skilled in working with cross-functional teams and clients.
- Familiar with budgeting processes for projects, personnel, equipment and lab space.
- Experience in regulatory submission to CFDA, FDA, and EMA.
Job Function: Research & Development