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 Scientist, Chemistry to provide technical leadership to both internal and external customers in the Analytical Chemistry laboratory.  Expertise will include fundamental knowledge in technical transfer and data integrity evaluation in relation to quality control testing.  This role will also author technical documents with quality assurance (QA) oversight. Additionally, the role will involve testing of samples, data review, and support of key business non-testing activities including customer support, in accordance with cGMP regulations and departmental procedures.

• Drive change control and technical documentation to completion.
• Representing Quality in driving new technical method qualifications and modalities from internal and external customers.
• Representing Quality in completing data integrity assessments for new instrumentation and Modalities.
• Provide customer facing support to existing and potential clients.
• Perform routine sample testing and data review.
• Expert level applied knowledge and in-depth understanding of analytical techniques including advanced assays.
• Demonstrated proficiency and ability to work independently.
• Provide scientific incite for laboratory investigations, determine root cause for laboratory errors, and identify appropriate corrective/preventive actions for laboratory errors.
• Accurately document laboratory work.
• Be knowledgeable of current regulations pertaining to area of expertise.
• Provide scientific incite for trends or results.
• Provide scientific incite in determination of instrument performance checks/calibrations and participate in new instrument qualifications.
• Provide scientific oversite of troubleshooting of instrumentation and methods. Recognize instrumentation and method issues and provide recommendations to management to resolve them.
• Provide scientific review during revision of SOPs as required.
• Actively seek to improve/obtain new technical skills and share learnings with department.
• Serve as an in-house expert for assays in area of expertise including recognition as an expert user of related instrumentation and computer systems.
• Participate in filing review activities for area of expertise.
• Maintain and promote a safe working environment

Education/Experience/ Licenses/Certifications:

• Minimum B.S. degree in a scientific area with greater than five years’ experience, M.S. degree with 4 years’ experience, or Ph.D. 
• Experience working in a cGMP laboratory is required.

Specific Knowledge, Skills, Abilities, etc: 

• Demonstrated expert level theoretical and technical knowledge in area of concentration; skills, hands on training, and cGMP experience within the laboratory setting are required.
• Expert level instrumentation experience in area of concentration.
• Familiarity with pharmaceutical regulations and general compendia (USP/EP/JP) methodology and instrumentation requirements is required.
• The candidate must be self-directed with a high degree of professional integrity, be organized, and detail oriented.
• Demonstrated problem solving ability and effective technical trouble shooting is required.
• Strong interpersonal, oral and written communication skills required.
• Demonstrated ability to prioritize objectives from multiple projects and adhere to scheduled timelines while maintaining flexibility and attention to detail and to contribute to a team based, collaborative, and positive environment ensuring clarity of purpose and high commitment to business goals.
• Demonstrated ability to work independently.

Physical Demands:

Frequent repeated motions such as pipetting, lifting, bending, twisting, squatting, crouching, kneeling, climbing on stepstools, and reaching is required.  This role also requires frequent unassisted lifting (not to exceed 50 lbs.).  Repetitive use of arms/hands/wrists and grasping is also required.

Work Environment:

This position is office based; however, it requires intermittent laboratory testing and requires the use of appropriate levels of personal protective equipment (PPE).  This role will require safe interaction with biohazardous materials. Powdered materials and high temperature liquids and solids are also handled. This position is based indoors and primarily involves working with others, but also independently at times. This position is a team-based position that may require shift work, weekends, and holidays.

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.