As the Head of Biologics Manufacturing you will, provide direction and tactical leadership to the Biologics Manufacturing, including upstream, downstream, Formulation and fill finish.
You will oversee, manage, and direct the initiatives and daily activities of the biologics manufacturing operations. You will collaborate with support departments to ensure manufacturing production goals are achieved and performed in compliance with current good manufacturing practices (cGMP) required by US FDA, EMA and CDE. You will review procedures on an on-going basis, seeking ways to improve efficiency, enhance safety and ensure compliance with regulatory agencies. You will ensure all project deadlines and performance standards are established and met. – First time right principle -. You will assist with the planning and development of the department’s budget. You will also support, direct, and coach subordinate employees.
The ideal candidate will have a Master or Ph.D. Degree from an accredited college or university and a minimum of 8 years management level experience in pharmaceutical manufacturing and/or process development, preferably in biologics.
The ideal candidate will also have demonstrated knowledge and be skilled in:
- Working knowledge of Current Good Manufacturing Practices (cGMP) and other regulatory requirements
- Technical knowledge of drug substance/product manufacturing processes, equipment procedures and systems
- Pharmaceutical principals, practices, and their application
- Principals of mathematical and statistical computations
- Principals and practices of budget preparation, tracking and administration
- Implementing goals, objectives and practices for effective, efficient and cost effective management of allocated resources
- Analyzing and trouble-shooting problems, identifying solutions, recommending and implementing methods, procedures and/or techniques for resolution
- Functioning as a team leader, coach and mentor, and managing, directing, and coordinating the work of staff
- Directing, supervising, coordinating, delegating and reviewing the work of assigned department personnel
- Lean manufacturing principals and practices
- Superb communication skills, both orally and in writing
- Languages: fluent in English and Chinese
- Establishing and maintaining cooperative working relationships with individuals contacted in the course of work
- Management practices and techniques
- Demonstrated effective leadership.
Location: Qidong, Jiangsu Province, China