자격요건
- 학력 : 대졸(4년제)이상 /바이오, 생명과학, 유전공학, 생화학, 분자생물학, 약학 등 관련 전공 - 동종 업종 경력 10년 이상 - 단백질 의약품 생산 개발 경험 보유 - 미국 메릴랜드 소재 회사 근무 * 주거지 제공(가족과 함께 생활 가능)
우대사항
- cGMP Biologics manufacturing (Bioreactor, Chromatography, Viral clearance 등) 경험자 우대 - Single Use manufacturing 경험자 우대 - 경력 : 관련 업무 경험자 우대
담당업무
? Biologics manufacturing -Upstream and downstream process operation, maintenance, and documentation ? Organize storage rooms, perform cycle counts, data entry to maintain a cGMP inventory system thus ensuring all our departments have adequate access to the materials they need. ? Collaborate with Manufacturing, Quality Control, and Quality Assurance in supporting internal and external materials management operations, and resolution of issues. ? Perform timely batch record review to identify and address deficiencies in timely manner to facilitate on time product release. ? Identify, investigate, and author procedural deviations in a timely manner. ? Assist in the preparation of reports and other documentation as applicable to the scope of operations in the manufacturing facility. ? Identify areas for improvement in manufacturing efficiencies and compliance. ? Communicate effectively with management of any processing or equipment issues. ? Routinely monitors, cleans, prepares and operates sophisticated automated cell processing, cell expansion and filling equipment in Grade B/C clean room
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