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Job Description:
The upstream manufacturing manager position is available in Biologics Manufacturing Department at ChemPartner in Shanghai. As the manager of upstream manufacturing, you will report to Sr. Director, Head of Biologics Manufacturing. In this position, you will provide tactical leadership to the upstream manufacturing group and be responsible for upstream cell culture manufacturing performed in compliance with current good manufacturing practices (cGMP) required by CFDA, US FDA and EMA. You will collaborate with downstream manufacturing group, fill/finishing group, process development and other supporting departments to ensure upstream production goals are achieved according to project schedule.
Qualifications:
The ideal candidate will have a BS/MS degree in Biochemical Engineering, Chemical Engineering, Biochemistry or related field from an accredited college or university and a minimum of 5 years working experience in a cGMP environment. Extensive working knowledge in cell culture at pilot and/or commercial scale is required. Management experience with years of progressive experience in biologics manufacturing is a plus. The successful candidate must be a goal-oriented team player with excellent communication skills and adaptive to a quality and time-line driven work environment.
The ideal candidate will also have demonstrated knowledge and qualification in:
？ Working knowledge of Current Good Manufacturing Practices (cGMP).
？ Technical knowledge of cell culture manufacturing processes, equipments, procedures and systems.
？ Previous experiences in cell culture scale-up, technology transfer including drafting production batch records, technology transfer and process qualification protocols etc., are highly desired
？ Hands-on experience in equipment, process qualifications and regulatory requirements.
？ Responsible for scheduling and coordinating the upstream manufacturing work to meet project timeline.
？ Familiar with deviation investigation, CAPA implementation and cGMP quality system.
？ Functioning as a team leader, coach, mentor, and managing direct reports.
？ Directing, supervising, coordinating, delegating and reviewing the work of assigned department personnel.
？ Excellent communication, organization and collaborative skills are essential. Ability to read, write and speak in English is required.
