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 Manager, Antibody Drug Conjugate Operations (ADC) Shift Manager. Given the start up nature of our organization, this role will evolve over the next several years:

Initial Phase: The Antibody Drug Conjugate Operations Shift Manager is responsible for supporting and driving the facility design, build out, start-up, qualification, and manufacturing processes for Antibody Drug Conjugates (ADCs) and other bioconjugate molecules. This individual will work in a team-driven environment on customer projects to enable transfer to GMP manufacturing. During facility build and start-up phases this role will influence process and organizational design.

Final Phase: As the facility transitions to the release phase, this role will be responsible for operational readiness including facility and equipment qualification support as well as management of a team of Associates in a shift-based environment. Following start up, the Shift Manager is accountable for the safety of the team, ensuring a quality driven workforce, continuously challenging inefficiency and process loss at every opportunity. This individual will be responsible for establishing a team culture of continuous improvement and the unrelenting pursuit of excellence.

Duties/Responsibilities:

• Lead a Health and Safety culture within operations; ensure the team consistently sets site safety best practices by demonstrating zero tolerance behavior, continually challenging, and raising Safety standards.
• Provide technical input in support of equipment procurement including bid package preparation, bid evaluation, vendor selection.
• Support start-up and commissioning activities (FAT/SAT/IQ/OQ/PQ) including the preparation of test protocols, test execution, troubleshooting, and change control, all per cGMP guidelines.
• As the Senior Manager, part of a team ensuring delivery of operational activities in Downstream of Antibody Drug Conjugate manufacturing, e.g., tech transfer support, material planning, document and batch record preparation, training and troubleshooting, deviation handling.
• Ensure efficient operation of single-use and/or stainless-steel equipment for the purification of therapeutic proteins from either microbial or mammalian expression systems or for the manufacturing of therapeutic Bioconjugates like Antibody Drug Conjugates (ADCs)
• Accountable for compliance with all safety, GMP, and corporate policies and procedures.
• Accountable for reporting of all safety incidents and quality deviations that occur on shift.
• Accountable for the supervision and execution of all manufacturing operations and support activities within assigned shift.
• Accountable to resolve escalation requests by prioritizing work activities and communicating with necessary stakeholders.
• Accountable for implementation of OPEX principles in manufacturing including standard work, 5S, visual management, human error reduction and tier meetings.
• Accountable for area inspection readiness and provides direct audit support.
• Provides coaching and mentoring. Regularly meets with staff to discuss performance, career, and development.
• Conducts personnel and team performance management including objective setting, performance appraisal reviews and succession planning.
• Leads Tier 2 meetings and ensures proper escalation of shift issues while ensuring engagement of all cross functional team stakeholders ·
• Participate in or lead daily area GEMBA walks that focus on safety, compliance, efficiency, and waste elimination. ·
• Collaborates with site and network groups to meet site objectives.

Remote Position

Min Compensation

Max Compensation

Bonus

Qualifications

Education/Experience/ Licenses/Certifications:

• 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 biologics manufacturing or equivalent industry experience of 8 years with minimum of 3 years of previous supervisory experience which demonstrates proficiency in selection of team and effectively managing personnel issues is required. 
• Work experience in the biotech/biopharma industry leading and managing complex projects including equipment start up and commissioning activities is highly desirable.
• Extensive knowledge of SOPs and cGMPs and the know-how to work and manage within a regulated environment.
• Strong knowledge of biopharmaceutical manufacturing processes with a proven record in biopharmaceutical technology
• Adaptable to a fast paced, complex, and ever-changing business environment

Specific Knowledge, Skills, Abilities, etc:

• The ideal candidate will have experience with common downstream unit operations such as tangential flow filtration, dead-end filtration, and protein chromatography.
• Strong working knowledge of cGMP practices, FDA/EMA, compliance requirements, OSHA requirements, etc.
• Strong understanding of safety dangers (steam, pressure, chemical, etc.) and best practices for safe working behaviors.
• Demonstrated ability to successfully coach and develop 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.

Physical Demands:

This position requires infrequent unassisted lifting (not to exceed 50 lbs.). This position will be a shift-based position as the buildout project transitions from start up to full production. A rotating shift model including weekends and holidays will be required.

Work Environment:

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

Travel:

This position requires up to 5% of travel.

Supervisory Responsibilities:

Will supervise a direct staff of 4-10 employees with department level managerial responsibilities.

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.