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 Sr Bioprocess Associate II, Cell Culture on the night shift green team. The primary role of the Senior Bioprocess Associate II is following detailed procedures and batch records ensuring compliance with cGMP and safety requirements. This role 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 a medium-scale cell culture facility with classified areas requiring appropriate personal protective equipment (PPE). Additional gowning through the processing areas and maintaining clean hygiene is a requirement to control established environmental specifications. This role 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 Bioprocess Associate II will serve as temporary Shift Supervisor.

Duties/Responsibilities:

• Leads critical operations on control systems and processes supporting biologics process manufacturing.
• Acts as a primary subject matter expert for all production equipment within the assigned functional area (i.e. media formulation equipment, glass washers, bioreactors, harvest equipment, buffer equipment, chromatography skids, membrane operations, column packing skids, aseptic handling of mammalian cell culture, aseptic filling of final drug substance, conducting scale-up operations,)
• Maintains files, records data, logs activities, and monitors processes. 
• Prepares process buffers, media, and reagents.
• Cleans and Steam sterilizes equipment and maintains area in a clean and orderly fashion to support the manufacturing schedule. 
• Recognizes and reports safety, maintenance, and quality events to area management. 
• Communicates status of operations to area management in a timely manner.
• Achieves and maintains proficiency through training.
• Assists with reviewing batch and exception reports for each manufacturing lot in conjunction with Quality representative.
• Engages in and supports culture of continual improvement through ownership of improvement for work processes, equipment and safe work environment.
• Champions areas specific initiatives associated with work safety
• Consistently leads and trains others on complex/critical operations.
• Serve as designee for Shift Supervisor as required (duties including but not limited to: daily task assignment, investigational support, project schedule and maintenance coordination)
• Provides support for engineering projects and departmental continuous improvement initiatives
• Provides content and review of new/updated manufacturing documentation (i.e. SOPs, WIs, MBRs)

Min Compensation

Max Compensation

Bonus

Qualifications

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. Experience in aseptic technique and mammalian cell culture is desired A minimum of 4 years process operations experience in a biotechnology manufacturing facility subject to current Good Manufacturing Practices (cGMP) regulations.

Specific Knowledge, Skills, Abilities, etc:

• Prior job-related experience required along with demonstrated mechanical aptitude and high level of attention to detail.
• Prior process operations experience in a biotechnology manufacturing facility or related industry subject to current Good Manufacturing Practices (cGMP) regulations.
• Demonstrated proficiency in common computer tools such as word processing, spreadsheet and web-based applications.
• Practical knowledge of regulations such as cGMP and Standard Operating Procedures (SOP).
• Familiarity with general chemistry, mathematics, microbiology and cGMP operations is desirable.
• Work/study experience where attention to detail, adherence to written instruction, and personal accountability were critical to success
• Demonstrated abilities for problem solving, successful participation on work teams where combined contribution, collaboration, and results were expected
• 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.
• Demonstrated ability to lead a positive, collaborative, inclusive environment to achieve team goals.
• Demonstrated ability to solve complex problems where individual decision making is required
• Posses the ability to role model LOTTE behaviors and support implementation of change.

Physical Demands:

This position is located a medium scale manufacturing facility with classified areas requiring appropriate personal protective equipment (PPE). This role will require contact with hazardous materials such as caustic, acids and steam. 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, lab space and office space. The environment includes limited exposure to noise ( > 85 dBA), hazardous chemicals and equipment temperature extremes.

Supervisory Responsibilities:

In the absence of a shift supervisor this role may require temporary assignment of some supervisory duties such as task assignment, real time review, and direct interaction with EHS, Quality and Maintenance.

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.