Responsibilities

• Responsible for product transfer, process validation, and process improvement.

• Responsible for all aspects of clinical manufacturing in the following areas: Cell Expansion, Cell Culture, Purification, Solution Preparation and Weigh/Dispense. Employee will lead and work seamlessly across all areas and will be a Subject Matter Expert (SME) for multiple areas.

• Strong partnership with Quality to support manufacturing operations and to support Quality and Compliance at all times.

• Ensure systems and staff are prepared for inspections by regulatory authorities and customer audits.

• Specify processing requirements in support of product and quality related topics.

• Monitors and controls all aspects of manufacturing processes using data trending and /or statistical process control. 

• Works cross functionally to ensure process is controlled and issues are escalated and investigated. 

• Analyse process and facility capabilities to identify opportunities for improvement.

• Lead the transfer of products/processes from and to Aragen CCM.

• Provide technical support to the front-line operations support groups in the Manufacturing Department to troubleshoot and improve process operations.

• Design and execute laboratory experiments targeted at improving process robustness

Leadership & People Management

• Develop Aragen’s CCM group to meet goals in staff development, group effectiveness, efficiency, process improvement, customer service, and safety.

• Establish culture of strong team spirit, effective communications, sense of urgency, high motivation and inspire team to achieve short and long-term goals.

• Manage groups organizational growth and development including hiring, promotion, and compensation and provide training of personnel on company’s and department policies systems and processes.

• Demonstrates problem solving abilities and is change advocate

Financial

• Plan, develop and oversee CCM budget

Required Educational Qualification & Relevant experience

• Minimum of Master’s degree in the life sciences or in an engineering discipline (Ph.D. preferred).

• At least 10 years of experience in the GMP cell culture manufacturing

• At least 7 years of managerial experience

• Knowledge/Skills/Competencies:

• In depth knowledge of Biopharmaceutical manufacturing processes and GMP requirements.

• Excellent written and verbal communication skills.

• Strong team leader with demonstrated ability to manage complex projects, lead technical teams, and support manufacturing operations in a flexible and dynamic team environment.

• Experience in leading, motivating, developing, and sustaining creative output from a diverse technical staff.