This is an exciting opportunity to lead Project Management and Tech Transfer related manufacturing activities for biologics manufacturing. This is a once-in-a-lifetime expatriate leadership opportunity within the World's Largest biologics CDMO/CMO expanding to 720 KL total mammalian cell culture manufacturing capacity with commercial monoclonal antibody, mRNA vaccine and ADC manufacturing capabilities. You will be charged with the following activities:
* Managing CDMO/CMO Project schedules, timelines, project scopes and business processes with clients, including project master schedule generation and updates.
* Serving as a primary point of contact for communications between external CDMO/CMO Clients and internal teams to facilitate tech transfer projects.
* Managing regular weekly and monthly client communications relating to forecasting, manufacturing schedules, change controls, deviations, risk assessments and mitigations.
* Overseeing Project Change Request management, including generating and managing Scope of Work (SoW), confirming contract scope and alignment, and managing change orders for additional scope of work.
* Managing Core Teams and cross-functional client communications for critical issues, including arranging and leading regular/ad-hoc meetings with associated teams.
* Providing technical leadership and subject matter expertise relating to Project Risk Assessment, Process Control Systems, deviations, change controls, process optimization, and technical troubleshooting.
* Working cross functionally with Process Development, Validation, Facilities Engineering, Manufacturing, Quality and Regulatory departments relating to process improvements, process change controls and deviation investigations.
Desired Skills & Experience
* BS in Biochemical Engineering, Chemical Engineering, Biochemistry, Biology, Chemistry or related Life
Sciences/Engineering field.
* 8+ years of BioPharma, BioPharmaceutical, Pharmaceutical or Biotechnology industry experience.
* Project Management leadership experience managing tech transfer processes between client companies and CMOs.
* Experience leading projects relating to manufacturing deviations, change control, process optimization,
technical troubleshooting, and manufacturing process changes.
* Biologics manufacturing expertise manufacturing large molecule biologics including monoclonal antibodies, Antibody Drug Conjugates, fusion proteins or bispecific antibodies. Experience working within a biologics CMO/CDMO a plus.
* Strong experience working cross functionally within a BioPharma Manufacturing organization leading projects across Process Development, Manufacturing, Quality, Regulatory and Engineering Services departments.
* PMP or Lean Six Sigma certifications a plus.
*** Please note that this is a full-time Expat Opportunity Based in South Korea. It is not based in the US or remote from the US. A full Expat Benefits package is provided including a company paid apartment, international school tuition and relocation assistance. ***
Expatriate Benefits Package:
* Competitive base salary, target bonus, retirement allowance and excellent medical benefits.
* Company paid luxury apartment in Songdo.
* International school tuition paid for children at the top rate Chadwick International School in Songdo, 3 miles from SBL - www.chadwickinternational.org There are also excellent English speaking preschools.
* Company paid airfares to visit the US (or country of origin).
* 3 weeks of vacation time.
* Opportunity to rapidly advance your career within the World's Largest Biologics CMO. A majority of Expats we have placed are now working in their 4th, 5th, 6th and even 9th years. Many have been promoted up to Sr. Director and VP levels.
* Work alongside a friendly team of over 100 US Expats and live within the amazing Songdo international community. Other Songdo community employers include the United Nations Green Climate Fund and Incheon Global Campus with University of Utah, SUNY Stony Brook and George Mason University.
* Opportunity to live and work in the ultramodern New Songdo city with excellent restaurants and an abundance of shopping. Just 20 minutes away from the Incheon ICN International Airport, trips to the US is easy and Asia travel opportunities are endless.
You can also view new photos of Korea and Songdo at https://www.linkedin.com/pulse/laguna-source-korea-2024-jeff-schwartzman-uvsyc