15 Mar, 2023

ISCO - Technology Transfer Engineer (Cell Culture Media, 10년 이상)

  • Merck
  • Incheon, South Korea
Engineer Biochemicals / Pharmaceuticals

Job Description

[Your Role]

 

  • 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.

 


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