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 Manager, Purification Manufacturing Operations (Yellow - Nights) to provide first line supervision of operation and matrix reporting support staff.  The supervisor is responsible for Biologic Operations schedule execution including area cleaning, environmental monitoring, maintenance, operations and validation activities on a 24 hour/7 day per week schedule.

• Provides process oversight, spending 90% of shift time out on the production floor
• Responsible for ensuring that all manufacturing and support activities are carried out to the highest standards of GMP and EHS compliance
• Responsible for adherence to manufacturing and support activity schedule
• Provides regular feedback and performance coaching to the manufacturing operators
• Holds regular discussions on career development with direct reports
• Responsible for personnel and team performance management including performance connections, acceleration of development action plans and succession planning
• Responsible for real time review of all manufacturing documentation
• Ensure that all batch documentation generated on shift has been fully completed prior to shift exchange
• Responsible for communication of progress and escalation of non-conforming events
• Responsible for managing  Tier 1 meeting and communication board in manufacturing area 
• Responsible for initial data gathering and reporting of safety incidents and deviations and entry into relevant systems
• Makes process decisions and provides troubleshooting within scope of established procedures
• Responsible for permit writing and approval for within boundary of manufacturing
• Responsible to ensure proper handoff for manufacturing equipment and rooms
• Ensures that the area is inspection ready at all times by conducting daily GEMBA walks and weekly GMP walkthroughs with QA Field
• Performs weekly time management system approval of non-exempt staff
• Accountable to ensure all staff are trained and proficient in accordance with the job functions assigned
• Responsible to champion OPEX principles in manufacturing including standard work, 5S, visual management, human error reduction and tier meetings
• Supports implementation of CAPA into routine manufacturing operations
• Responsible for review of procedural updates as part of CAPA implementation or errors identified by operators during execution

• Knowledge of science generally attained through studies resulting in a B.S. in science, engineering, biochemistry or related discipline, or its equivalent is highly desired.
• Direct biologic manufacturing experience of 6+ years. Previous supervisory experience is desirable
• Extensive knowledge of working in a regulated environment and the importance of following procedures, cGMPs and EHS and the skillset  to work and manage within a regulated environment
• Strong knowledge of biopharmaceutical manufacturing processes with a proven record in biopharmaceutical technology
• Strong change management skills and demonstrated ability to simplify and improve business processes
• Excellent leadership skills with the ability to motivate and manage a team with matrix reporting relationship
• Adaptable to a fast paced, complex and ever-changing business environment
• Effective verbal and written communication skills with technical writing skills
• Proficiency in the use of computers and business software applications
• Yellow and/or green belt certified in lean manufacturing/operational excellence

Specific Knowledge, Skills, Abilities, etc:

• Strong working knowledge of cGMP requirements and regulations FDA, EMA
• Strong working knowledge of both local, state and OSHA requirements in relation to environmental, health and safety.
• Strong understanding of safety hazards (steam, pressure, chemical, etc.) and best practices for safe working behaviors.
• Qualified trainer with ability to successfully coach and supervise people and teams.
• Ability to create an environment of trust, compliance, safety, continuous improvement and learning.
• Excellent problem solving, decision making and communication skills.
• Change agent with demonstrated history of continuous improvement.
• Strong knowledge of MS Excel, Word and PowerPoint is preferred.
• Ability to work across the matrix to direct and support critical functions that support manufacturing including maintenance and quality.

Physical Demands:

This position requires infrequent unassisted lifting (not to exceed 50 lbs.).  This position is a team based position that requires rotating shift work, weekends and holidays.  The hours on this position at 6pm-6am on a rotating 48/36 hour schedule. 

Work Environment:

This position is for a supervisory position in a manufacturing facility with classified areas requiring appropriate gowning and personal protective equipment (PPE). This role will require working with hazardous conditions and materials such as caustic, acids and steam.  Powdered materials and high temperature liquids are also handled.

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.