담당업무

ㆍManage global CDMO – timeline, budget, resources and contracting

ㆍReview and approval manufacturing/CMC related documents

ㆍInvoice management – review invoices from CDMO

ㆍMain liaison between manufacturers (lead regular meetings with CDMOs)

ㆍParticipate Regulatory affairs/clinical affairs related meetings

ㆍManage internal/external manufacturing/CMC related documents

ㆍCollaborate with RA members for CMC development

학력 사항

ㆍBachelor’s Degree or higher graduate degree from the biomedical/bioscience/bioengineering background and/or discipline

경력 사항

ㆍExcellent English language skill and no difficulty in conversing in English

ㆍ5+ years of professional experience in Research & Development/Manufacturing area of biopharmaceutical industry

ㆍExperience in PLI/inspection from global regulatory agencies

ㆍExperience in clinical material manufacturing for global late phase development or global commercial manufacturing experience

ㆍKnowledge of GxPs including GMP, GDocP and GDP and other manufacturing related regulations

ㆍGood interpersonal communication skills

ㆍCompetent computer skills

우대 사항

ㆍExperience in PFS development/manufacturing

ㆍExperience in CMC development

ㆍNative English speaker