Microbiology 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 a Microbiology Scientist, Quality Control - Antibody Drug Conjugate (ADC) to provide leadership and microbiological expertise to both internal lab technicians and external customers in ADC in defined areas of microbiological expertise including bioburden, endotoxin, microbial identification, growth promotion, and general laboratory procedures.

Duties/Responsibilities:

• Provide technical expertise, leadership and guidance to the Quality Control team on establishment of laboratory procedures and practices, method qualification studies, and various projects needed to support operation of the ADC QC laboratory.
• Troubleshoot, maintain, and support qualification activities including data integrity assessments associated with laboratory equipment and instrumentation.
• Prepare, review, and interpret technical data and documentation from routine testing and studies, prepare trend reports and metrics.
• Lead laboratory investigations, eCCs, and CAPA as well as provide technical support for cross-functional investigations, as applicable.
• Assist with troubleshooting and resolution of complex issues.
• Author, review, and approve laboratory SOPs, test methods, risk assessments, protocols, technical reports, and other documentation related to QC microbiological testing.
• Apply knowledge and understanding of cGMPs, compendia, and regulatory requirements to microbiological laboratory testing and associated studies.
• Serve as Subject Matter Expert and support regulatory inspections and audits in areas of expertise.
• Maintain current knowledge on microbiological industry issues and/or trends including new or revised regulatory requirements and share knowledge across the organization, as applicable.
• Conduct/approve periodic review of procedures and microbial studies as required to assure adherence to current regulatory requirements.
• Identify/execute continuous improvement opportunities to reduce operational variances and improve laboratory efficiency using lean principles.
• Lead multiple projects simultaneously to support implementation of updated and/or new methods, instruments, and materials.
• Assist with mentoring, developing, and training employees on microbiological techniques and regulatory requirements.
• Work across organizational boundaries to share best practices and support network initiatives to achieve alignment of company objectives.

Education/Experience/ Licenses/Certifications:

• Knowledge of science generally attained through studies resulting in a B.S. in physical or life sciences (e.g. microbiology, biochemistry, molecular biology, or related discipline).
• Minimum 5 years of experience in a cGMP Biopharmaceutical environment with previous microbiology laboratory experience.
• Demonstrated technical knowledge in microbiological quality control testing procedures, aseptic technique, equipment/instruments, and cross-functional investigations.
• Experience interpreting and applying cGMP concepts, compendia, and regulatory requirements to daily laboratory operations and associated method studies and projects.

Specific Knowledge, Skills, Abilities, etc:

• Demonstrated technical expertise in aseptic technique and microbiological testing procedures including bacterial endotoxin testing, bioburden testing, microbial identification, and various laboratory techniques, instruments, and equipment.
• Ability to interpret and apply cGMPs, compendia, regulatory requirements, and industry best practices to laboratory operations and design of scientific studies.
• Demonstrated problem solving ability, attention to detail, and analytical thinking skills.
• Ability to take initiative, lead multiple projects with minimal supervision, and adhere to scheduled timelines while maintaining flexibility.
• Ability to provide leadership, direct and influence others in a team based collaborative environment.
• Knowledge of good documentation practices, cGMP, regulatory requirements, and ability to train others in areas of expertise.
• Ability to analyze, evaluate, and interpret data, and provide microbiological expertise to support cross-functional investigations.
• Ability to troubleshoot issues associated with methods, equipment/instruments, and laboratory procedures.
• Knowledge of applicable business systems including electronic laboratory systems, Delta V, Maximo, and SAP.
• Excellent written and verbal communication skills.

Physical Demands:

This is both an office and laboratory-based position that may require repetitive use of arms, hands and wrists, especially when working with computers. Depending on work demands, office-based work requires sitting.

Work Environment:

This position is an office-based position that will require entry into the laboratory that requires appropriate levels of personal protective equipment (PPE) and awareness of presence of workplace hazards including pressurized liquids, gases, high temperature water and steam, ultralow temperature cryogenic liquids and chambers, and hazardous chemical reagents. This position is based indoors, and primarily be working with others, but also independently and alone at times.

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.