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 Manager, Quality Logistics to support the onsite commercial manufacturing facility, and provides testing as a third party QC laboratory.  The Manager, Quality Control Logistics (Quality Shared Services (QSS)) manages QSS staff to enable daily operations in the testing laboratories to meet customer needs. Additionally, this position directs and supports method performance monitoring and data reporting activities. This position requires partnering with QC Operations, IT Quality Systems, and Quality Assurance as well as other internal and external customers to ensure efficient processes are designed/maintained to meet business requirements.

• Provide technical and strategic leadership in the development and maintenance of one or more areas including, but not limited to QC Data Analytics and Sample Submission Operations (SMO).
• Responsible for management and compliance of the QC data analytics program applications and operational activities.
• Responsible for overseeing management of regulatory reserve program, including drug substance and raw materials.
• Responsible for ensuring GMP compliance and performance of Sample Submission Operations responsible for storage, shipping logistics and related activities for Quality Control.
• Responsible for ensuring compliance with QC systems use and sample management requirements for raw material, water, microbial, biologics drug substance and biologics drug product testing.
• Provide leadership and guidance to ensure compliance with Site procedures and cGMP/GLP
• Provide leadership and guidance in the management of contract laboratory testing to support the timely release of product while ensuring good customer relationship/communication.
• Collaborate with IT Quality Systems team to develop processes in applicable QC system applications to support laboratory testing activities, monitoring, and reporting department metrics.
• Participate/support regulatory inspections and responses; lead tours and provide process overview of supervised areas with regulatory agency inspectors and internal auditors.
• Provide investigational support associated with sample handling and applicable data analytics applications and method performance.
• Ensure safe and compliant operations as well as overall inspection readiness of supervised areas.
• Recruit and develop high performing and diverse team. Create an environment for continued learning and innovation.

Education/Experience/ Licenses/Certifications:

• Minimum B.S. degree in a scientific area with 8 to 10 years’ experience, or M.S. degree with 4 years’ experience. Experience working in a cGMP laboratory preferred.
• Demonstrated leadership ability with excellent communicative skills to lead a team based, collaborative and positive environment, with clarity of purpose and high commitment to business goals.
• Demonstrated working knowledge of laboratory database applications (i.e. LIMS, LES, MODA) and various laboratory instrumentation systems and techniques preferred. 
• Demonstrated knowledge in the field of data analysis.
• Knowledgeable in regulatory requirements (i.e. US, EU, USP) and industry best practices and prior experience supporting regulatory agency inspections preferred.
• Self-directed with a high degree of professional integrity, very organized, and detail oriented.
• Excellent problem-solving ability and analytical/critical thinking skills.
• Ability to take initiative and prioritize objectives from multiple projects; adhere to scheduled timelines while maintaining flexibility, independently or as part of a team.
• Advanced knowledge with Microsoft Office Applications (Access, Excel, Project, PowerPoint, Word) and/or other relevant software programs such as JMP, PowerApps,etc.

Specific Knowledge, Skills, Abilities, etc:

• Expert level applied knowledge and in depth understanding of analytical techniques and data evaluation, preferred.
• Demonstrated leadership ability.
• Self-directed with a high degree of professional integrity, very organized, and detail-oriented.
• Excellent problem solving ability, attention to detail, and analytical/critical thinking skills.
• Ability to independently, proactively troubleshoot within QC system applications.
• Strong interpersonal, oral and written communication skills are essential, including the ability to communicate at all levels with clarity and precision.
• Ability to take initiative and prioritize objectives from multiple projects; adhere to scheduled timelines while maintaining flexibility, independently or as part of a team.
• Ability to interpret and apply cGMPs, regulatory requirements, and industry best practices.
• Must contribute to a team based, collaborative and positive environment, clarity of purpose and high commitment to business goals.
• Demonstrated ability to effectively train and assist other less experienced individuals.

Physical Demands:

This position is primarily an office-based position requiring sitting and repetitive use of arms/hands/wrists, especially when working with a computer.  This role may require donning of appropriate levels of personal protective equipment (PPE) for entry into laboratory spaces.  Walking within and between buildings is required to enter laboratories and collaborate with others. Lifting (not to exceed 50 lbs), bending, twisting, squatting, crouching, kneeling, climbing on step-stools, and reaching may be required.

Work Environment:

This role will require office-based work primarily working in a team environment, however, will also work independently and alone at times.  Entering to the laboratory areas will be required.  Workplace hazards exist including pressurized liquids, gases, and hazardous chemical reagents. This role may require working weekends, holidays, and off shift adhoc support.

Supervisory Responsibilities:

• Direct supervision of personnel within Quality Shared Services team
• Provide feedback, coaching, and performance evaluations to each direct report.

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.