1. 소속 헤드헌팅 회사명: 제이에이치에이치알-JHHR /
주소 : 서울시 강서구 마곡중앙 6로 21
2. 소속 헤드헌팅사 홈페이지: http://www.jhhr.co.kr
3. 소속 헤드헌팅사 회사 전화번호: 82-2-567-7407 (직통)
4. 소속 헤드헌팅사 회사용, 이메일 : jhkwak@jhhr.co.kr
5. 포지션 진행 헤드헌터명 및 직급 : 곽 지 혜 대표 컨설턴트


[그룹 계열사] Analytical CMC 모집

1.의뢰사:[그룹 계열사] - 제약 및 바이오

▣ Position : [그룹 계열사] Analytical CMC 모집


[자격요건]

'-Excellent scientific knowledge in analytical chemistry, strong analytical development experience for drug substance and drug product.
- Ability to effectively manage a team of highly-trained scientists to advance clinical candidates.
- Familiarity with a full range of analytical techniques for characterization of mRNA pharmaceuticals including RP/IEX/SEC HPLC, CGE, Agarose Gel, UPLC, LCMS, Karl Fisher, solid state characterization, CE spectrophotometry.
- Experienced in CMC product development process including; cGMP manufacturing, validation, and process development.
- Demonstrated competency and hands-on experience of typical chemistry manufacturing and controls (CMC) activities.
- Experience drafting analytical sections of INDs, NDAs, BLAs.
- Knowledge of GMP/ICH/FDA regulations is strongly preferred.
- Experience managing CROs and CMOs.
- Previous experience/knowledge of routine mRNA and LNP production and testing in support of Process Development and Research activities is desired, but not required.
- Reviews, interprets and communicates data cross-functionally within CMC and project teams.
- Ability to meet deadlines and demonstrate effective use of time.
- Ability to be flexible and responsive to change, be a results-driven problem solver




[직무내용]


- Manage analytical chemistry activities both internally and at external contract laboratories
- Manage a team of scientists that support the testing and characterization of numerous DP clinical candidates.
- Experienced with drug product characterization and managing vendors to support these activities.
- Guide CRO to design and perform method development and validation, employing phase-appropriate approaches at different stages of development
- Develop phase-appropriate quality control strategy for drug substance and drug product
- Manage product stability study programs
- Demonstrate extensive knowledge in state-of-the-art analytical technologies
- Authorize/review analytical method development reports, validation protocols/reports, instructions/SOP’s for relevant analytical functions, and analytical sections in IND and IMPD filings
- Manage internal analytical development laboratory and analytical personnel to support pipeline programs
- Provide technical advice to analytical scientists and associates to assure the highest quality of data is developed and presented






▣ 제출서류: 국문 이력서 및 상세 경력 기술서

▣ 진행절차 : 1차 서류 전형- 2차 면접전형 - 3차 최종면접

▣ 담당자: 곽지혜
연락처 : 82-2-567-7407(직통)
이메일 : jhkwak@jhhr.co.kr