職位描述
職位描述：
Job Description:
ChemParnter is seeking an individual to be a manager of a dynamic fast-paced biologics manufacturing organization. The successful candidate will lead a downstream manufacturing team responsible for the pre-clinical and clinical manufacturing of therapeutic proteins. In this position, incumbent will provide tactical leadership to the downstream manufacturing group and be responsible for downstream purification manufacturing performed in compliance with current good manufacturing practices (cGMP) required by CFDA, US FDA and EMA. This individual will have extensive working knowledge of cGMP manufacturing and hands-on experience in clarification, UF/DF, chromatography and membrane separations at pilot and/or commercial scale. This position will report to Sr. Director, Head of Biologics Manufacturing.
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:
？ BS/MS in Biochemical Engineering, Chemical Engineering, Biochemistry or related field with a minimum 5 years working experience in a cGMP environment.
？ Extensive hands-on experiences in protein purification at pilot and/or commercial setting are required.
？ Familiarity with operating of chromatography systems, TFF systems, as well as column packing and evaluation at pilot and commercial scales is also required
？ Previous experiences in technology transfer of purification process including drafting production batch records, technology transfer and process qualification protocols etc., are highly desired
？ Responsible for scheduling and coordinating the downstream 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.
？ Excellent communication, organization and collaborative skills are essential. Ability to read, write and speak in English is required.
