Location : Shanghai
Reporting Line：Global Head of CDMO Business
Manage the development department which includes: Upstream, Downstream development and Analytical lab units. Define and manage activities according to CHINA revenue targets, forecasted operation budgets and capabilities needs.
Manage the GMP manufacturing facility which includes: Upstream, Downstream, Cell Banking, QC lab units. Define and manage activities according to CHINA revenue targets, forecasted operation budgets and capabilities needs
Implement on site projects and capabilities within timing and budget as defined through goals.
Supervise all activities concerning different steps of a process development in line with agreed objectives (described process, timeline and budget) and respect the requirements of cGLP and requirements from health authorities as needed.
Oversee high-level project planning for CHINA Bio development activities. Coordinate development and GMP production scheduling between internal and external partners.
Support GMP production department for process trouble shooting or new equipment implementation when process is transferred. Ensure that new process and technologies are assessed and implemented on site.
Ensure the compliance of all activities performed in the labs (quality and safety levels).
To implement corrective and preventive actions in order to ensure the risk prevention of goods, persons and the service environment.
Ensure strict compliance of quality in the activities of the owner of the function and those of the staff under her/his responsibility.
Implement Environment, Health and Safety Regulations in compliance with Corporate EHS requirements and according to local regulation.
Interface with sales to enable project sales. Participate to the promotion of services in front of clients.
Liaises with the larger delivery organization to ensure alignment on process standards and procedures. Ensure Technical Transfers internally as well as to other sites and clients of processes developed and implemented locally.
Lead continuous improvement and efficiencies programs.
Create and appraise performance against the objectives and development plans for direct reports and consult in the same for indirect reports.
Ensure consistent and timely reporting of operations activities.
Participates in the Bio development strategy definition, communicate the vision and strategy of the company in a consistent, timely and open manner and build a culture of long-term commitment to the company.
Motivate the different groups in achieving their objectives according to quality, timelines, and budget
To ensure effective definition and delivery of the training plans to all staff.
To co-ordinate activities of the site and interact with other centers having Bio development activities.
To maintain an organizational culture of openness, teamwork and trust in the site and with our contacts within the Group.
To maintain the highest customer service Level.
Listen, analyze, motivate and manage a team. Promote, develop and improve others. Good relationships with other to solve problem and avoid conflicts.
Identification and development of talent: build succession plan within the organization
Correct documentation of the activities in development and services.
Master of Science Degree or above
Major in Biochemistry, Chemical Engineering, Biotechnology, Bioengineering, Pharmacy or equivalent
Good competencies in budget establishment and cost control monitoring programs.
Expertise in management of technical activities.
Strong interpersonal skills and ability to interact constructively with all functions in a matrix organization environment.
First-hand experience in international pharmaceutical and/or biotechnology companies.
Sound awareness of cGMP related issues & Health Authorities as well as local laws and regulations.
Experience or sound awareness of Health, Safety and Environment local regulations.
Demonstrated success records in position which influences and interacts with other departments.
Strong results orientation.
Fluent in English