Sr./Principal Scientist, ADC Conjugation & Manufacturing
Full Time
Los Angeles, CA 90001
Posted
Job description
This is a stellar opportunity responsible for leading ADC conjugation processes, tech transfer and manufacturing operations. This is a once-in-a-lifetime Global Expat leadership opportunity within the World's Largest biologics CMO expanding to 620,000L total mammalian cell culture manufacturing capacity with commercial monoclonal antibody, mRNA vaccine and Cell Therapy manufacturing capabilities. You will be charged with overseeing the following activities:
Leading the optimization of processes for low-yield, highly sensitive ADC conjugation processes.- Incorporating various generations of external site-specific conjugation platform technologies.
- Running processes beyond large scale and small scale with consideration of scalability (i.e., commercial and clinical scale).
- Providing input on payload handling procedure set up and for facility design from a human safety perspective.
- Supporting the standardization of processes and communications to build efficiency within cross-functional teams.
- Assisting and providing input for facility process design, equipment validation and equipment selection.
- Providing support for document generation (SOPs, batch records, etc.).
- Leading and supporting the technical process clarification with clients.
- Providing input and supporting facility design processes.
- Supporting quality audits and global regulatory inspections.
10-15+ years working experience with ADC biopharmaceuticals, including manufacturing process development.- BS, MS or Ph.D. in Biochemistry, Biology, Organic Chemistry, Chemistry, or related Biological Sciences degree.
- Experience working with cross-functional, multi-national teams and capability to build an environment with productive collaboration.
- Proven experience with ADC conjugation processes, tech transfer and manufacturing operations for commercial ADCs and monoclonal antibody therapeutics.
- Significant knowledge of DAR (Drug-Antibody Ratio) and identification of binding sites (Cysteine, lysine, etc.).
- Experience leading and managing the ADC conjugation manufacturing set up (including ADC DP) and operations.
- Familiarity with FDA guidance on analytical method development for ADCs and monoclonal antibody therapeutics.
- Experience contributing to CMC, IND and BLA regulatory filings and submissions.
- thirty
About the Company:
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 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. Just 20 minutes away from the Incheon ICN International Airport.
You can also view photos of Korea and Songdo at - http://instagram.com/lagunasource and https://www.linkedin.com/pulse/laguna-source-korea-2022-jeff-schwartzman/
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