Director BioPharma Drug Product Fill Finish – Laguna Source – Seoul, South Korea
Director BioPharma Drug Product Fill Finish – South Korea
This is an exciting US expatriate leadership position responsible for overseeing all Fill & Finish activities within an emerging Global Contract Manufacturing Organization (CMO) backed by a major multinational corporation. You will be charged with overseeing the following activities:
* Processes related to fill/finish in regards to filling, packaging, labeling, and logistical support for clinical trial products as well as large scale manufacturing.
* Handling of complex and highly automated systems and overseeing all state-of-the-art equipment including formulation, aseptic liquid filling, pre-filled syringe lyophilization, and packaging apparatus.
* Responsible for daily operation on the production floor, including scheduling, staffing, training, and troubleshooting to ensure that all operations are in full compliance with applicable BPRs/EBRs, SOPs, and safety guidelines.
* Driving the reduction of Cost of Goods through budgetary, financial and logistical management.
* Overseeing that all processes are cGMP compliant and are designed to meet the regulations of the U.S FDA and the EMEA.
* Serving as Fill/Finish department representative during FDA and other international regulatory body audits.
* Ensure quality and integrity of small scale batches for clinical trials, to large scale batches for commercial production.
Preferred Candidate Background and Expertise:
* BS in Biochemical Engineering, Chemical Engineering or related Scientific/Engineering field.
* 15+ years of BioPharma, BioPharmaceutical, Pharmaceutical or Biotechnology industry experience.
* Experience with aseptic liquid filling of vials, aseptic lyophilization filling of vials, and aseptic preparation of pre-filled syringes.
* Experience with cold-chain inventory management, including refrigerated and frozen capabilities.
* Knowledge of cGMP’s and applicable agency regulations (such as the FDA, EMEA) to
ensure PAI and inspection readiness of department.
* Knowledge of Six Sigma/Lean Manufacturing, Green Belt certification a plus.
About the Company
*** Please note – This position is located near Seoul, South Korea. A full relocation package plus the following Expatriate Benefits Package is provided for this position. *** Expatriate Benefits Package: * Company paid housing in South Korea. * International school tuition paid for children. http://www.chadwickinternational.org The school is exceptional! * Full Korean and US healthcare/medical insurance benefits. * Company paid airfares to visit the US (or country of origin). * 3 weeks of vacation time plus 10-12 Korean Holidays per year. * Opportunity to live and work in the New Songdo city and Incheon Free Economic Zone (IFEZ). Songdo is a master-planned metropolis and is a model of sustainable green living, city-scale development, and innovation. Songdo city contains Dream City Shopping, Korea’s tallest building, international convention center, 100 acre Central Park, Jack Nicklaus Golf Club Korea championship golf course, subway access, and Chadwick International School – www.songdo.com