This is a leadership position within Process and Technical Development that has responsibility for developing downstream and harvest processes and platform technologies, from adherent and suspension cell culture processes for viral vector production. In addition, this role will lead the improvement of WuXi ATU's downstream process development capabilities.Responsibilities
QualificationsExperience / Education
- Oversee the Purification Technology Process Development group and work closely with the groups' managers and scientists to deliver robust downstream processes for a variety of viral vector and cell therapy products
- Develop and optimize harvest processes
- Have oversight of rapid analytical development team as appropriate
- Lead the downstream technology development team to develop and implement platforms and assist in technology transfer to GMP manufacturing facilities.
- Partner with China team, as needed.
- Interface with clients for process development and technology transfer as needed. Guide the technical team.
- Lead IP development for downstream process in cell and gene therapies
- Participate in scientific conferences and represent WuXi to potential clients where appropriate.
- Stay current on technologies to maintain the organization's long-term competitive position
- Be able to connect with all levels within the organization
- Ability to work in a team environment and independently as required
- Maybe required to work Holidays and weekends
- Contributes to the overall operations and to the achievement of departmental goals
- Perform job specific tasks in compliance with applicable Regulations, International Standards, and WuXi AppTec Policies and Standard Operating Procedures.
- Thorough understanding of Good Laboratory Practices and Good Manufacturing Practices
- Other duties as assigned
- May be required to assist in other departments
Knowledge / Skills / Abilities:
- More than 10 years of Biopharm / Biotech industry experience
- Ph.D. in Science and Engineering Discipline
- Mid Management level experience
- Experience in analytical development, is a plus.
Equal Opportunity Employer Minorities/Women/Veterans/Disabled
- Track record of successful development and tech transfer of high efficiency viral vector or biologics purification processes to GMP manufacturing
- Understanding of the Intellectual Property landscape for the field.
- Demonstrated ability for critical thinking and innovation
- Proficient in Oral & Written communication skills
- Able to understand and communicate risks, and develop and execute
- Travel requirement ~10%