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[Your Role]
- Act as tech transfer engineer for the new investment project in S. Korea forLife 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 Technology Transfer Lead to optimize processes, introduce new products, implement lessons learned from giving sites, FMEA risk assessments, etc.
- Plan and coordinate the transfer of manufacturing processes and technologies from giving sites to commercial manufacturing
- Collaborate with giving sites, engineering, and quality assurance teams to identify and address technical issues during technology transfer
- Develop and implement transfer protocols, procedures, and documentation
- Provide technical expertise and support to internal and external stakeholders during technology transfer
- Ensure that all activities related to technology transfer are in compliance with regulatory requirements
- Troubleshoot technical problems and recommend solutions to optimize the transfer of product or technology
- Participate in cross-functional teams to develop and implement new manufacturing processes and technologies
- Ensure that technology transfer activities are completed within the agreed timelines and budgets
- Develop and maintain strong relationships with internal and external stakeholders, including suppliers and contract manufacturers
- Follow Life Science Tech transfer SOP 00080018MP or updated version to execute tech transfer projects
- Develop and optimize local NPI flow from the base of tech transfer flow and other NPI flow
- Support Technology Transfer Lead by quickly identifying key attractions, fits, and mismatches including improvement opportunities
- Run NPI projects assigned by Technology Transfer Lead
- 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 in engineering, life sciences, or related field; advanced degree preferred
- + 3-5 years of experience in technology transfer within the biopharmaceutical industry
- Strong knowledge of cGMP and regulatory requirements related to technology transfer
- Good experience and knowledge of typical CCM processes such as formulation, blending, milling, filling, CIP, and related equipment
- Good experience and knowledge of typical Liquid processes such as formulation, hydration, sterile filling, CIP/SIP, and related equipment
- Good experience and knowledge of typical bag, bottle, syringe assembly and bag-making processes and related equipment
- Demonstrated ability to lead and collaborate in a cross-functional team environment
- Excellent communication and project management skills
- Experience with process validation and process improvement methodologies
- Familiarity with biologics manufacturing processes, such as cell culture and purification, is preferred
- Ability to work independently and prioritize multiple projects
- Good command of English and Korean in writing and speaking
- Good teamwork attitude, initiative, and hard-working, and good communication skills.
- 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.
• Áö¿ø ¼øÀ¸·Î ÀüÇüÀÌ ÁøÇàµÇ¸ç, ÀûÇÕÇÑ Èĺ¸ÀÚ ¹ß°ß ½Ã ä¿ëÀÌ ¹Ù·Î ¸¶°¨µÇ¿À´Ï Áö¿øÀǻ簡 ÀÖÀ¸½Å ºÐµéÀº ºü¸¥ Áö¿ø ¹Ù¶ø´Ï´Ù.
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• Áö¿ø¼ÀÇ ±âÀç»çÇ×ÀÌ »ç½Ç°ú ´Ù¸¥ °ÍÀ¸·Î È®Àεǰųª Reference from previous employer »ó¿¡ ä¿ë»óÀÇ °á°Ý»çÀ¯°¡ È®À뵃 °æ¿ì ÇÕ°Ý ¶Ç´Â ä¿ëÀÌ Ãë¼ÒµÉ ¼ö ÀÖ½À´Ï´Ù
• (The company reserves the right to withdraw the offer, it if discovers subsequently that a candidate has given false information in application or has provided false or fraudulent documentation in support of his/her application. The offer is conditional upon satisfactory results of reference checks.)
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