Analytical Scientist, Quality Control - Antibody Drug Conjugate (ADC) at LOTTE BIOLOGICS

Overview:

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 an Analytical Scientist, Quality Control - Antibody Drug Conjugate (ADC) to provide technical leadership to both internal lab technicians and external customers in ADC defined area of expertise.  Expertise will include fundamental knowledge in analytical testing, technical transfer, and data integrity evaluation in relation to ADC Quality Control (QC) testing laboratory.  The position will be authoring technical documents in alignment with subject matter experts and Sr. Manager’s with Quality Assurance (QA) oversight, as applicable. Additionally, this position will perform testing of release and In-Process samples, data review, and support of key business non-testing activities, in accordance with cGMP regulations and departmental procedures to support manufacture and release of ADC Drug Substance (DS).

Duties/Responsibilities:

• 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 assisting Instrument Life Cycle (ILC) in managing and completing data integrity and risk assessments for new instrumentation and modalities.
• Assure laboratory safety in the handling of liquid hi-potency product stream testing.
• Perform routine sample data review.
• Provide scientific understanding to drive laboratory investigations, determine root cause for laboratory errors, and identify appropriate corrective/preventive actions for laboratory errors.
• Be knowledgeable of current regulations pertaining to area of expertise.
• Provide scientific understanding for trends of analytical data 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 technicians for resolution.
• 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.
• Perform and review analytical methodology to support a cross functional team.

Education/Experience/ Licenses/Certifications:

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

Specific Knowledge, Skills, Abilities, etc:

• Demonstrated proficiency and ability to work independently, and successfully coach and supervise people and teams.
• 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.

Physical Demands:

Frequent repeated motions such as pipetting, lifting, bending, twisting, squatting, crouching, kneeling, climbing on stepstools, and reaching are 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 entry and requires the use of appropriate levels of personal protective equipment (PPE).  This role will require safe interaction with biohazardous and Hi-Potency liquid materials. Powdered materials as reagents 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 is a standard work week, The position will require occasional extended shift work, weekends, or holidays supporting and highly versatile manufacturing environment.  This occasional requirement will be scheduled in advance, managed with a flexible schedule, to meet work/life expectations.

Travel:

This position requires up to 5% travel.

Work Location:

East Syracuse, NY

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.