Job Title: Senior Director of Gene Therapy Vector cGMP Manufacturing Operations
Department: Gene Therapy Vector
Reports To: Vice GM
Location: Wuxi Huishan district
Responsible for the daily operations in Gene Therapy Vector manufacturing and facilities. Knowledge of cell and gene therapy manufacturing and support systems is essential. Demonstrated managerial skills and a strong working knowledge of the regulatory compliance.Responsible for hiring, training, supervising and evaluating staff. Remains current regarding technical manufacturing requirements and develops / modifies production methods to fully address such issues. Prepares validation protocols, SOPs, material specifications and develops new client master batch records. Manages Gene Vector manufacturing operations assuring customer satisfaction and compliance with appropriate regulatory standards including but not limited to the U.S. and China GMP regulations.
• Responsible for representing Manufacturing in the build-out, commissioning and validation of the GMP Gene therapy vector facility
• Determining staff and equipment resources.
• Identification and development of Standard Operating Procedures (SOPs), Master Batch Records, and Product Specification Sheets.
• Staffing and training of the assigned Manufacturing group to be competent in current Good Manufacturing Practices (cGMP).
• Interacts with Engineering, Maintenance, Validation, Quality Assurance, Quality Control, and Materials Management groups. As needed, interaction will be required with material/equipment vendors and clients.
• Supervises, plans and reviews operations for assigned staff, including responsibility for training, managing and evaluating as well as coordinating, scheduling and assigning work and maintaining facility’s standards.
• Recommends hire/transfer/promotion/discharge and salary changes and acts on employee problems.
• Conducts employee performance appraisals in a timely and objective manner.
• Maintains production schedule to meet customer and business goals.
• Provides accurate production forecasting methods with continuous improvement through capacity optimization and cost reduction programs.
• Implements and maintains personnel policies, procedures and production control systems.
• Ensures cGMP compliance, ensuring that all production equipment is properly validated and production processes meet quality standards.
• Minimum of 8 years supervisory experience and 10 years’ experience in biologics/Gene Vector manufacturing is required.
• Direct experience in gene/cell therapy manufacturing preferred.
• Has a thorough understanding of cGMP requirements
• Experienced in commercial manufacturing requirements for biological or cell or gene therapy products.
• Excellent communication skills, both oral and written.
• Demonstrated leadership skills.
• Ability to evaluate technical data and write technical documents.