Manager, Aseptic Quality Operations 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!
Responsibilities
To help us meet our mission LOTTE Biologics is in need of a Manager, Aseptic Quality Operations (AQO) to supervise AQO staff who are responsible for performing EM and Utility sampling and EM Laboratory operations. This organization is also responsible for providing technical expertise and guidance to support manufacturing operations and support functions that may include gowning, cleaning/disinfection, smoke studies and aseptic qualifications to ensure appropriate microbial control of low bioburden drug substance commercial manufacturing.

• Applies knowledge and in-depth understanding of microbial control, aseptic technique and processes.
• Supervise the daily AQO operations and schedule of the staff, in performance of EM and Utility sampling and EM laboratory operations.
• Recruit, lead, and develop high quality team members with diverse backgrounds and talent capable of delivering against established goals and objectives.
• Interface directly with manufacturing operations and support functions to provide microbiological technical expertise, leadership and guidance in area of environmental control.
• Prepare, review, and interpret technical data and documentation associated with environmental and utility monitoring, disinfectant efficacy studies, smoke studies and cleanroom gowning.
• Observes, coaches, trains and provides technical expertise and guidance to bioprocess associates in area of aseptic technique and behaviors including aseptic qualifications.
• Review and assist with investigations as well as provide technical support for cross-functional investigations, as applicable ensuring the identification of the root cause and corrective and preventative action to prevent recurrence. Assist with troubleshooting and resolution of complex issues
• 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. Interprets regulatory guidance documents, technical reports and assures adherence to regulatory compliance.
• Serve as Subject Matter Expert and support regulatory inspections and audits
• Maintain current knowledge on microbiological industry issues and/or trends including new or revised regulatory requirements and share knowledge across the organization, as applicable
• Accountable for compliance with applicable BMS 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
• Manage technical projects including preparation of project plans, change control, risk assessments, protocols, reports and investigations. Serve as project lead as applicable.
• Work across organizational boundaries to share best practices and support network initiatives to achieve alignment of company objectives

Remote Position
No
Min Compensation
USD $76,000.00/Yr.
Max Compensation
USD $113,000.00/Yr.
Bonus
10%
Qualifications
Education/Experience/ Licenses/Certifications:

• BS. degree in Biological Sciences or related field (e.g. microbiology, biochemistry, molecular biology, or related discipline) with minimum of 5-7 year experience in cGMP Biopharmaceutical environment with previous microbiology and aseptic process experience OR MS degree in biological Sciences or related field with 3 years -5 years experience.

Specific Knowledge, Skills, Abilities, etc:

• Demonstrated leadership, interpersonal, communication, motivational, problem solving, and analytical skills. Ability to direct and influence others in a team based collaborative environment.
• Demonstrated technical expertise in microbial control strategies, aseptic technique and processes including environmental & utility monitoring, cleaning and disinfection, aseptic gowning and qualifications
• 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
• Extensive knowledge of regulatory requirements (e.g. FDA, EMA, USP, EP, etc) and industry best practices
• Knowledge of applicable business systems including LIMS, Infinity, MODA, Delta V, CMMS, etc.
• Experience in health authority inspection (FDA, EMA, etc) preparation and management

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.