We are LOTTE Biologics! A new company, built on 80 years of tradition!

We embody our core values of being Inspired by Science, Embracing Diversity, Fostering Talent, and Connecting Lives. Our mission is to be the most trusted partner in the industry, with high standards of quality and continuous innovation, to reliably deliver benefits for patients worldwide.

We deliver therapies that make a Healthier World!

To help us meet our mission LOTTE Biologics is in need of a Director, Manufacturing Sciences & Technology (MS&T) who will be will be accountable for developing, managing, and retaining bench strength and leadership across the MS&T function through coaching, mentoring, and providing development opportunities to the following teams: Manufacturing Support, Upstream and Downstream Process Development, and Analytical Science and Technology. The Director, MS&T will liaise with clients and partner organizations to transfer and support new product introduction and development, improvements, troubleshooting, investigation and commercializing of manufacturing processes and analytical methods. The successful candidate will have strong technical, scientific, management and leadership skills, experience in early process development through commercialization of biologics, process and analytical technology transfer, project management and the ability to influence across functions. The role will report to the General Manager and will drive the analytical and process CMC throughout the product life cycle.

• The position will direct a group of scientists and engineers to drive the development and technical transfer of mammalian and ADC processes and methods from preclinical to commercialization.
• Lead the preparation and review of documentation, compiling and analyzing of process data, deviation investigations, change controls, and CAPAs.
• Review and/or approve internal and CMC documents such as: process descriptions, structure and impurity characterization, comparability protocols and reports, justification of specifications, PPQ reports, and relevant sections of regulatory filings (IND, BLA, etc.) and responses. Remain current on Health Authority guidance and expectations.
• Lead phase-appropriate risk-based qualification strategies for manufacturing process steps and analytical methods for in-process testing, release, characterization, and stability, aligned with the goal of commercialization and ensure application of these requirements throughout the product lifecycle.
• Work closely with Clients, Manufacturing, Quality, QC, Supply Chain, and F&E to ensure successful implementation of cGMP drug substance manufacturing processes and testing programs.
• Lead the evaluation, remediation and optimization of methods and processes using statistical tools to ensure safety, quality, delivery and cost control. Enhance productivity by exploring, analyzing, facilitating and leveraging efficiency initiatives.
• Develop budget plans and make recommendations on staffing requirements to meet departmental goals. Monitor department expenses and makes recommendations on departmental capital budget items.
• Manage department including establishment of strategic plan, effective delivery of objectives and KPI, project resourcing, mentoring, training, goal setting, department structure, and performance evaluation.
• Develop risk-based strategies for analytical and process validation of commercial products and ensure application of these requirements throughout the product lifecycle.
• Familiarity with and constant attention to the evolving landscape through literature review/publication, conference attendance, industry working group leadership, etc.
• Provide technical direction and support to manufacturing and analytical organizations, including on-the-floor support of process, investigating deviations leading technical transfer.

Education & Experience

• PhD in Biotechnology, Chemical or Pharmaceutical Engineering, or related field, with minimum of 8 years of relevant experience; or M.S./M.A with minimum of 12 years of relevant experience; or B.S./B.A. with minimum of 14 years of relevant experience.
• Experience establishing, developing, transferring, and qualifying/validating manufacturing processes and analytical test methods for biologic products is required
• Strong leadership experience, with a minimum of 5 years managerial experience
• Experience with Regulatory requirements and authoring for analytical and process related topics across the product life cycle is required
• Experience bringing biologics from pre-Clinical to Commercial is preferred.
• Experience planning and conducting stability programs is preferred
• Demonstrated success working with or for a CDMO
• Experience with critical late-stage regulatory activities for biologics such as extended characterization, comparability assessments and attribute risk assessments is preferred.

Knowledge& Skills

• Ability to use Excel, Word, and other office and GMP systems.
• Expertise in cell banking, cell culture, media & buffer preparation, chromatography, filtration, and operation and troubleshooting of stirred vessels, bioreactors, incubators, chromatography, column packing and filtration steps, at both Laboratory and Manufacturing scales of operation.
• Demonstrated understanding of multiple applicable analytical techniques.
• Understanding and application of Risk Assessment tools (Hazard Analysis, FMEA, etc.).
• Demonstrated ability to provides reliable and defendable interpretations of regulatory guidance for the customer and the organization and ability to defend these positions to regulatory agencies.
• Technical/scientific knowledge of biopharmaceutical processes
• Knowledge of process scale-up and scale-down methodologies, including process characterization design of experiments
• Experience with Statistical and multivariate analysis software (e.g. JMP), data historian software (e.g. OSI /PI) and process data management (e.g. Discoverant)
• Demonstrated experience leading troubleshooting efforts.
• Hands on aseptic processing experience.
• Must have demonstrated understanding of FDA, EMA, and ICH regulations for biologics.
• Ability to speak and read Korean is a plus.

We believe that women, people of color, veterans and LGBTQ communities must participate in the work we do, so we strongly encourage applications from people with these identities or who are members of underrepresented communities.  If this is the work that you want to do in a culture of inclusion and excellence with the goal of making our world to be a healthier place, then please apply today! 

http://www.lottebiologics.com/

LOTTE BIOLOGICS was established in 2022, and is headquartered in Seoul, South Korea. LOTTE BIOLOGICS entered the biologics CDMO business after acquiring Bristol Myers Squibb’s Syracuse biologics drug substance manufacturing site, as of January 1, 2023!

The newly established organization aims to become a Global Top 10 CDMO company in the biopharmaceutical industry.  With initial operations in 1948 in Japan, LOTTE has grown to become the fifth-largest conglomerate corporation in South Korea. LOTTE has various business units, including petro/fine chemicals, food, retail, hotels, electronics, construction, and IT. LOTTE has 30+ global locations across the US, Europe, and Asia.

An Equal Opportunity Employer

We do not discriminate based on race, color, religion, national origin, sex, age, disability, genetic information, or any other status protected by law or regulation. It is our intention that all qualified applicants are given equal opportunity and that selection decisions be based on job-related factors.