Director/Head, Adc Manufacturing Business Operations

This is a stellar opportunity charged with starting up and leading Technical and Business Operations for 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 720,000L total mammalian cell culture manufacturing capacity with commercial monoclonal antibody, mRNA vaccine and new ADC manufacturing capabilities. You will be charged with overseeing the following activities:

* Driving and leading the overall ADC business operations including team management, project execution and business delivery including the setting of business goals, resources and budgets.

* Driving the startup of ADC plant operations including process development, GMP facility management, process development, scale-up, tech transfer into manufacturing and supply chain operations.

* Providing team leadership, mentoring and overall team oversight for process development and production operations teams.

* Leading the development & optimization of highly sensitive ADC conjugation processes ensuring quality and safety.

* Providing input on payload handling procedures and for facility design from a human safety perspective.

* Developing and incorporating site-specific antibody conjugation platform technologies.

* Supporting the standardization of processes and communications to build efficiency within cross-functional teams.

* Partnering directly with Business Development teams serving as ADC SME and engaging with prospective clients.

* Providing input for facility process design, equipment validation and equipment selection.

* Providing support for GMP document generation including SOPs and batch records.

* Leading and supporting technical process clarification with clients.

* Supporting FDA/EMA quality audits and global regulatory inspections.

Desired Skills & Experience

* 10-15+ years working experience with ADC biopharmaceuticals, including manufacturing process development.

* MS or Ph.D. in Biochemistry, Biology, Organic Chemistry, Chemistry, or related Biological Sciences degree. MBA or Advanced Business Degree a plus.

* Proven technical experience with ADC conjugation processes, tech transfer and manufacturing operations for commercial ADCs and monoclonal antibody therapeutics.

* Financial and Business Operations experience managing P&Ls, complex budgets and financial resources.

* Experience managing ADC safety operations including the safe handling of cytotoxic payload compounds as well as adhering to proper EHS standards.

* Project Management leadership experiences as well as Lean Six Sigma experience.

* Experience contributing to CMC, IND and BLA regulatory filings and submissions with the FDA and EMA.

Company Description

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/