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 Sr Material Operations Associate who will be responsible for following detailed procedures and batch records ensuring compliance with cGMP and safety requirements.  The Senior Material Operations Associate works on assignments that are moderately complex in nature, where judgment is required in resolving problems and making routine recommendations.  Work is performed in a team environment within multiple areas of the facility including unclassified and classified areas requiring appropriate personal protective equipment (PPE).  Additional gowning through the classified areas and maintaining clean hygiene is a requirement to control established environmental specifications.  The Senior Material Operations Associate is a senior member of a team and will be leveraged to ensure compliance with cGMP requirements, safety, and production schedule of junior staff.  When required, the Senior Material Operations Associate will serve as temporary Shift Supervisor.  

Duties/Responsibilities:

• Fully trained and proficient in all aspects of Material Operations Associate I, II, and III role.
• Serve as designee for shift manager as directed when training and qualifications are appropriate.
• Scheduler for area department tasks and work assignments.
• Technical SME for assigned area.
• Engages in and supports culture of continual improvement through ownership of improvement for work processes, equipment, and safe work environment.
• Champion for areas specific initiatives associated with work safety.
• Provides on the floor leadership, oversight and ownership of activities and facility.
• Review of GMP documentation including but not limited to MBRs, eLogs, Forms, Logbooks.
• Demonstrate knowledge and ability to review/revise/author SOP and/or other departmental documents.  Demonstrate ability/experience with training staff on variety of topics.  Capable of leading department projects or supporting management on projects as required.
• Able to act as area SME for all relative area functions and processes.
• Able to support Health Authority and/or internal inspections.
• Conduct routine inspections for safety, housekeeping, and compliance.
• Direct staff and maintain daily manufacturing schedule and tasks.
• Responsible for maintaining maintenance, compliance with PM, Calibration, and Cleaning processes.
• Maintain applicable training requirements and oversee operator adherence to training requirements.
• Perform additional activities at management discretion.
• Fully trained in applicable quality related system (Infinity or other) to enter/support investigations, impact assessments, etc.
• Ability to schedule/lead small scale meetings and cooperate with site partners to achieve departmental/site goals.

Education/Experience/ Licenses/Certifications:

The successful candidate will have a high school diploma.  Knowledge of science generally attained through studies resulting in a B.S. in science, engineering, biochemistry, or related discipline or its equivalent is desired but not required.  A minimum of 5 years related experience in a biotechnology manufacturing facility subject to current Good Manufacturing Practices (cGMP) regulations or 1 year experience with bachelor’s degree in related field.

Specific Knowledge, Skills, Abilities, etc:

• Prior job-related experience required and high level of attention to detail.
• Demonstrated proficiency in common computer tools such as word processing, spreadsheet and web-based applications.
• A well-rounded supply chain/material handling background within a regulated GMP environment, buffer/media make up or sampling background, is preferred.
• Work/study experience where attention to detail, adherence to written instruction, and personal accountability were critical to success.
• Demonstrates good interpersonal skills, is attentive and approachable with the ability to embrace a team-based culture.
• Demonstrated ability to communicate expectations and results to the operating staff and management as needed to maintain production timelines and organizational goals.

Physical Demands:

This position is located in a medium scale manufacturing facility with unclassified and classified areas requiring appropriate personal protective equipment (PPE).  This role will require contact with hazardous materials such as caustic, acids and extreme cold temperatures.  Frequent bending, twisting, squatting, kneeling, climbing, and reaching is required. Role also requires infrequent unassisted lifting (not to exceed 50 lbs). Repetitive use of arms/hand/wrists, grasping is also required.  This position is a team-based position that requires shift work, weekends, holidays, and overtime.

Work Environment:

The work environment involves activities in a medium scale manufacturing facility, warehouse, dispensing, cryogenics, and office space. The environment includes limited exposure to noise ( > 85 dBA), hazardous chemicals and equipment temperature extremes

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.