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Director, Downstream Purification, Biologics Manufacturing expat in South Korea
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Laguna Source
Burlingame, CA (In Person)
Full-Time
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Job Description
Director, Downstream Purification, Biologics Manufacturing expat in South Korea at Laguna Source Director, Downstream Purification, Biologics Manufacturing expat in South Korea at Laguna Source in Burlingame, California Posted in about 20 hours ago.
Type:
full-timeJob Description:
This is an exciting foreign expat opportunity responsible for leading downstream manufacturing operations for large scale commercial manufacturing for the generation of monoclonal antibodies, Antibody Drug Conjugates, and other complex large molecule biologics. This is a once-in-a-lifetime Global Expat project leadership opportunity within a startup state-of-the-art biopharmaceutical Global CDMO drug substance manufacturing facility. You will be charged with overseeing the following activities:- Providing technical project leadership relating to downstream related manufacturing deviations, change control, process optimization, technical troubleshooting, and manufacturing process changes.
- Serving as a technical/scientific Subject Matter Expert for downstream protein purification activities ranging from column chromatography, filtration (UF, DF, TFF), harvest and recovery.
- Supporting technical troubleshooting and deviation investigations related to downstream manufacturing processes.
- Executing downstream purification processes including chromatography, filtration, and UF/DF operations.
- Working cross functionally with MSAT and Engineering teams to support downstream related manufacturing process improvements, technology transfers, process validation, process change control, deviation investigation and process characterization activities.
- Managing scale down validation studies, process range studies, process robustness studies, and manufacturing troubleshooting activities.
- Monitoring critical process parameters to ensure consistent process performance and product quality.
- Managing organizational technology transfer processes including the authoring of tech transfer documentation including
PCS, GAP
reports, Process FMEA, Campaign Summaries and Process Validation documents.- Interfacing and engaging with global BioPharma clients and partners throughout Business Development, Product Lifecycle and Technology Transfer projects.
- Ensuring all plant safety policies and procedures are met within GMP compliance and other global regulatory standards. Desired Skills & Experience
- BS, MS or Ph.D. in Biochemical Engineering, Chemical Engineering, Biochemistry, Biology, Chemistry or related Life Sciences/Engineering field.
- 10+ years of BioPharma, BioPharmaceutical, Pharmaceutical or Biotechnology industry experience.
- Strong Scientific and Engineering technical experience performing downstream protein purification manufacturing activities involving column chromatography, filtration (UF, DF, TFF), harvest and recovery for the manufacturing of recombinant protein and monoclonal antibodies.
- Experience leading projects relating to process validation, manufacturing deviations, change control, process optimization, technical troubleshooting, and manufacturing process changes within cGMP, FDA and EMA compliance.
- Expertise involving Plant Operational Excellence, QbD (Quality by Design), scale down studies, process range studies, PAT, statistical analysis, process robustness studies, Lean Manufacturing and Six Sigma methodologies.
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 - 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 a rapidly expanding Global CDMO. A majority of Expats we have placed are now working in their 4th, 5th, 6th and even 10th years. Many have been promoted along the way 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, Celltrion, Merck 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.