15 Mar, 2023
Incheon, South Korea
Biochemicals / Pharmaceuticals
- Act as tech transfer lead for the new investment project in S. Korea for Life Science. The candidate will be responsible for transferring technology related to the CCM (dry-powder and liquid media), process liquid (buffer, solvent, etc.), sterile sampling systems, and filtration products during project phases (design, construction till commissioning, qualification, start-up, and future plant routine operation).
- Support Operation Readiness Lead and Production Lead to optimize processes, introduce new products, implement lessons learned from giving sites, risk assessments, etc.
- Follow Life Science Tech transfer SOP 00080018MP or updated version to execute tech transfer projects
- Be the tech transfer workstream lead in all product introduction projects on the site
- Lead the receiving site process engineering team and coordinate cross-function teams in the technology transfer such as production, quality, regulatory, sourcing, building engineering, equipment, and etc.to ensure know-how transfer from sending site(s) as per project requirements.
- Responsible for process qualification
- As a primary contact in liaison with giving site teams
- Responsible for customers or authorities audits on tech transfer part
- Develop and optimize local NPI flow from the base of tech transfer flow and other NPI flow
- Support Operation Readiness Lead and Production Lead to screen NPI projects by quickly identifying key attractions, fits, and mismatches including improvement opportunities
- Run NPI projects assigned by management
- Ensure the smooth technology transfer from oversea giving sites to S. Korea new plant
- Support production start-up, ramp-up and continuous improvement from cost reduction, yield increase, efficiency improvement and quality control perspective via systematic methodology e.g. Six Sigma, Lean, VSM etc.
[Who you are]
- Bachelor’s degree or above in pharmaceutical, biological, or chemical engineering
- Extensive professional experience 10+ years in pharmaceutical, chemical, biological, or medical device industries with deep understanding and hands-on execution of GMP projects
- Good experience and knowledge of chemical or pharmaceutical industries in operations, R&D, tech transfer or NPI
- Ability to work effectively across the matrix organization including all departments in operations plus regulatory, controlling, legal and commercial team
- Good experience and knowledge of typical CCM, Liquid processes such as formulation, blending, milling, filling, CIP, and related equipment
- Good experience and knowledge of typical bag, bottle, syringe assembly and bag-making processes and related equipment
- Ability to work effectively across the matrix organization interacting with global colleagues, design company, equipment vendors, and cross functional teams.
- Good command in English and Korean in writing and speaking.
- Good teamwork attitude, proactive and hardworking, good communication skills.
- As for the work location, it will be currently located in Song-do, but it will be changed to *Sihwa or *near Daejeon area according to the site decision later.