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 Assistant Scientist, Aseptic Quality Operations (AQO) . The AQO group supports the onsite small scale commercial manufacturing facility. The Assistant Scientist conducts routine microbiological environmental and utility monitoring in compliance with procedures, protocols and regulatory requirements. The Assistant Scientist performs lab analysis of environmental samples according to defined procedures.

Duties/Responsibilities:

• Conducts routine microbiological sampling and analyses of environmental monitoring and a variety of clean utility samples using aseptic technique and in compliance with established procedures and regulatory requirements.
• Prepares and reviews test results and technical documentation associated with the daily operations of the AQO Sample Group, which performs a wide variety of regulatory, microbiological analyses to evaluate environmental samples using aseptic technique and in compliance with established procedures and regulatory requirements.
• Position serves as a technical support lead and resource for environmental monitoring testing.
• Analyzes, evaluates, and interprets data assisting to resolve issues, if applicable. Trend data and prepare trend reports, as required.
• Conduct and review investigations of deviations and environmental monitoring excursion results as required.
• Participates in risk assessments, as it relates to microbiological technical nature for evaluation and implementation of improved processes whether it relates to laboratory operations, facilities, or manufacturing operations.
• Conduct training of technical personnel to assure monitoring occurs in a manner that is efficient and compliant with cGMPs requirements, and regulatory expectations.
• Updates and writes new procedures, protocols, and reports, as required.
• Conducts environmental monitoring qualification studies, according to scientific protocols.
• Maintains accurate records of work performed and documents results, according to good documentation practices and established procedures as well as perform data entry into LIMS.
• Promotes quality, safety and health, by ensuring clean work area, and adherence to procedures and safety culture.
• Participates and leads continuous improvement using lean principles to assist with streamlining and making the AQO sampling operations efficient by identifying opportunities for workflow and procedural improvements.
• Maintains a level of technical knowledge and understanding in the assigned area of responsibility, including aseptic sampling, use of equipment and instrumentation and is able to troubleshoot problems, if they occur.
• Supports the implementation of new equipment/instrumentation by performing required testing in support of validations, and qualifications.

Remote Position:
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Min Compensation :
USD $58,000.00/Yr.
Max Compensation :
USD $72,000.00/Yr.
Bonus:
8%
Qualifications:

Education/Experience/ Licenses/Certifications:

B.S. degree in Biological Sciences or related field with 0-3 years of environmental monitoring experience.

Specific Knowledge, Skills, Abilities, etc:

Knowledge of aseptic technique, environmental monitoring, and microbiological Quality Control testing and procedures.

Excellent manual dexterity and aseptic technique.

Ability to complete sampling or work assignments in a timely and compliant manner, with minimal supervision.

Perform limited interpretation of data.

Demonstrate ability to handle multiple assignments simultaneously and complete assignments in a timely and compliant manner, with minimal supervision.

Knowledge of cGMPs and regulatory expectations required.

Must have effective verbal and written communication skills.

Physical Demands:

This position is a manufacturing facility, office and lab-based position which requires appropriate levels of personal protective equipment (PPE). This role will require contact with biohazardous materials such as live cell cultures and other hazardous chemicals including, acids, and caustics. High temperature liquids and solids are also handled. Frequent repeated motions such as pipetting, lifting, bending, twisting, squatting, crouching, kneeling, climbing on step-stools, and reaching is required. This role also requires frequent unassisted lifting (not to exceed 50 lbs). Repetitive use of arms/hands/wrists and grasping is also required. Depending on the work demands, office-based work requires sitting.

Work Environment:

This position is based indoors in a medium scale manufacturing facility, as well as in a laboratory setting, and primarily working with others, but also independently and alone at times. This position is a team-based position that may require shift work, weekends, and holidays. You will be dealing with temperature extremes (heat/cold) for short durations, as well as noise = >85 dBA.

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 Squibbs 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.