유명 바이오 제약회사에서 다음과 같이 '분석 전문가 (Researcher)'를 찾고 있습니다.
* Position: Researcher (Sr. Researcher)
* Department: Analytics Group
* Location: Songdo

[RESPONSIBILITIES]
(Team Objectives)
Developing, qualifying and validating analytical methods that will be used for protein characterization as well as Drug Substance / Drug Product lot release testing according to relevant ICH guidelines and GMP regulations

(Sub Projects)
1. Physicochemical analytical method development
2. Biologics analytical method development and characterization

(Job Functions)
1. Analytical development, method transfer and quality control functions in support of in-process, release and stability testing of drug substance and drug product for the global biosimilar or biologics programs
2. Analytical method development and method validation experience for biologics
- GMP QC lab experience: > 3 years
- Experience for method transfer activity
- Method validation protocol & report experience
3. Physicochemical characterization for biologics
- Experience for protocol/report of characterization study
4. Stability study manager for biologics

(Job Development)
Short-Term Plan (2~3 years)
- Analytical development, method transfer and quality control functions in support of in-process, release and stability testing of drug substance and drug product for the global biosimilar or biologics programs

Long Term Plan
- GMP QC lab manager
- Analytical method development lab manager

[QUALIFICATIONS]
(Education)
- Biochemistry, Analytical Chemistry or related fields - Bachelor Degree with a minimum of 6 years of relevant experience, or Master Degree with a minimum 4 years with relevant experience

(Experience)
- A minimum of 4 years of experience in the biotechnology/pharmaceutical industry, including a minimum of 2 years’ experience involving analytical method development and qualification in a R&D facility making biopharmaceutical drug substance and/or drug product for US and/or EU
- Experience related to biosimilar development programs (Monoclonal Antibodies & other fc-fusion proteins) will be considered an advantage
- Good communication (oral and written) and presentation skills
- In depth knowledge of current regulatory requirements for chemistry in support of cGMP operations supporting clinical and commercial manufacturing
- Preferred Skills: Review and revise analytical methods, method transfer SOPs, validation protocols, method validation reports and contribute to regulatory filings
- Problem-solving and decision-making skills

Those who are interested in this opportunity, please submit your Resume in MS Word Format by email urgently  Only qualified candidates will be contacted for interview  All resumes not contacted will be kept in DB confidentially for future positions

Kyung Jin KIM
CEO & Executive Search Consultant
Exdigm Inc
Phone: 070-8260-3646
Mobile: 010-8722-1272
Email: ceo@exdigm.com