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Bio-Manufacturing Director or Senior Director_Biologics

Responsibilities

• Supervise daily upstream/downstream manufacturing activities and ensure production timelines are met.
• Collaborate with Process Development and Project Management groups technical transfer and process validation
• Collaborate with QC & QA groups to ensure GMP compliance, manage deviation investigation and CAPA implementation, and support client auditing and agency inspections.
• Provides working knowledge and technical leadership in cell culture/purification operations.
• Schedules and/or delivers training to manufacturing personnel to ensure staff can perform manufacturing operations safely and compliantly.
• Motivate, retain, develop existing group members and recruit new staffs to build a strong upstream/downstream manufacturing team
• Contributes to continual improvement of all manufacturing documentation (SOP’s MBR’s, OJT’s) to ensure they are current, accurate, and clear.
• Communicate operational status regularly to senior director, as required, at the appropriate level of detail.
• Assist the director to coordinate the work between the upstream/downstream groups and other functional groups to meet the production objectives and timelines.
 

Basic Qualifications:

• BS/MS in a scientific discipline or equivalent is preferred.
• Minimum 6-8 years working in a cGMP biological manufacturing environment with previous experience managing subordinates and/or leading project teams.
• Experience in the large-scale chromatography, centrifuge and depth filtration harvest, ultrafiltration/diafiltration, and viral inactivation and removal
• Must be a strong leader able to adapt to daily challenges of manufacturing work environment while maintaining positive and productive attitude and fostering this attitude among subordinates.
• Must be quality focused with knowledge and understanding of cGMP quality systems and how they apply to manufacturing operations.
• Experience in working with the cross-functional teams.
• Experience in troubleshooting and investigation of the critical deviation, and making the risk analysis on the development, technical transfer and process validation.
• Must possess good interpersonal skills and the ability to communicate well, both verbally and written. Fluent in both Chinese and English.
• Good multi-tasking and prioritization skills.

 

Any applications, pls contact: ru_miaomiao@wuxiapptec.com; global_talent@wuxiapptec.com