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!

Responsibilities

To help us meet our mission LOTTE Biologics is in need of an Associate Scientist/Sr Specialist, Aseptic Quality Operations (AQO) to support the environmental and utility monitoring program and microbial control strategies to ensure appropriate microbial control of commercial manufacturing.

Duties/Responsibilities:

• Collaborates with manufacturing operations and support function colleagues to provide microbial expertise to assure environmental control.
• Performs data review and approval of test results.
• Prepare, review, and interpret technical data and documentation associated with environmental and utility monitoring including design of studies for environmental and utility qualifications.
• Conducts laboratory investigations and assist with manufacturing investigations by providing scientific and operational input as it relates to microbial related investigations. Assists with identification of CAPA and implementation.
• Assist with disinfectant efficacy studies, smoke studies and cleanroom gowning.
• Observe, coach, train and provide technical expertise and guidance to bioprocess associates in area of aseptic technique and behaviors including aseptic qualifications.
• Author, review, and approve technical documents including trend reports, protocols, reports, SOPs, Work Instructions, risk assessments, and other documentation related to microbial control of manufacturing operations. Recommends and makes changes ensuring consistency with other sites procedures.
• Apply knowledge and understanding of cGMPs, compendia, and regulatory requirements to microbial control and associated studies. Knowledge of regulatory guidance documents, technical reports and assures adherence to regulatory compliance.
• Serve as Subject Matter Expert and support regulatory inspections and audits
• Accountable for compliance with applicable LOTTE Policies, Guidelines, SOPs, and Directives and ensure consistency with site procedures and/or specifications
• Identify, participate, and lead continuous improvement to reduce operational variances and improve efficiency using lean principles
• Assists and supports purchase and implementation of new technology
• Anticipate and assist troubleshooting of instrument/ equipment issues and applicable software applications/electronic systems
• Support technical projects including preparation of change control, risk assessments, protocols, reports and investigations. Serve as project lead as applicable.

Min Compensation

Max Compensation

Bonus

Qualifications

Education/Experience/ Licenses/Certifications:

• B.S. degree in Biological Sciences or related field (e.g. microbiology, biochemistry, molecular biology, or related discipline) with minimum of 5 years experience in cGMP Biopharmaceutical environment with previous microbiology and aseptic process experience.

Specific Knowledge, Skills, Abilities, etc:

• Demonstrated interpersonal, communication, decision-making, problem solving, analytical skills and attention to details. Ability to direct and influence others in a team based collaborative environment.
• Demonstrated technical expertise in environmental & utility monitoring with knowledge of microbial control strategies, aseptic technique and processes
• Ability to take initiative, support multiple projects with minimal supervision, and adhere to scheduled timelines while maintaining flexibility
• Knowledge of regulatory requirements (e.g. FDA, EMA, USP, EP, etc) and industry best practices
• Knowledge of applicable business systems including LIMS, Infinity, Delta V, CMMS, etc.

Physical Demands:

Primarily office-based role in which one must be aware of the presence of general office based ergonomics requiring repetitive use of arms, hands and wrists, especially when working with computers. Depending on work demands, office based work requires sitting. Due to required entry into manufacturing facility, it requires ability to don additional gowning including sterile garments.

Work Environment:

This position is an office based position with occasional exposure to laboratory and manufacturing facilities where one must don appropriate gowning and personal protective equipment and be aware of the presence of workplace hazards including pressurized liquids, gases, high temperatures and steam, hazardous chemicals and microorganisms. Position requires working with others but also independently and alone at times.

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! 

Company Website

http://www.lottebiologics.com/

Company Profile

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.