Analytical Validation Engineer, Antibody Drug Conjugate (ADC) at LOTTE BIOLOGICS

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!

To help us meet our mission LOTTE BIOLOGICS is in need of an Analytical Validation Engineer, Antibody Drug Conjugate (ADC). As a key member of our newly established ADC facility, this role is essential for the successful implementation, commissioning, and ongoing support of analytical instrumentation and systems specific to the development and manufacturing of antibody-drug conjugates. This role will be responsible for planning, managing, and executing the validation and qualification of new and existing analytical equipment, developing validation project plans, and ensuring compliance with regulatory standards. This role will also serve as a technical expert, providing guidance to cross-functional teams and facilitating effective communication between project stakeholders.

Duties/Responsibilities:

• Develop and maintain validation documentation for computerized and non-computerized analytical laboratory instruments specific to ADC processes, including but not limited to Validation Plans, URS/FRS, Risk Assessments, and Qualification Protocols (DQ, IQ/OQ, PQ).
• Coordinate directly with the Analytical Validation Manager for the execution and oversight of validation projects, ensuring alignment with facility goals and regulatory compliance.
• Engage with laboratory SMEs to address technical challenges, understand instrument applications in ADC processes, and ensure robust qualification activities.
• Drive the completion of validation activities, collaborating closely with cross-functional teams within the ADC facility.
• Monitor project timelines and milestones, providing regular updates to the Analytical Validation Manager and escalating issues as necessary.
• Ensure adherence to global pharmacopeia standards and regulatory requirements relevant to ADC manufacturing.
• Participate in Instrument Comparability Studies relevant to ADC processes, working in collaboration with SMEs and cross-functional teams.
• Assess vendor qualification protocols for compliance with internal and regulatory standards.
• Ensure a safe working environment, adhering to safety protocols and company policies throughout the validation process.
• Support regulatory and internal audits, acting as an SME and ensuring the ADC facility meets inspection readiness standards.
• Contribute to the maintenance of validation documentation, SOPs, and training materials, ensuring they are up to date and compliant.
• Play a key role in change control assessments, providing expert recommendations and supporting continuous improvement initiatives.

Educational/Experience:

Bachelor of Science (BS) degree in Engineering, Chemistry, Biological Sciences, or a closely related field, complemented by relevant experience in the biopharmaceutical or pharmaceutical industry, particularly in antibody-drug conjugate (ADC) development and manufacturing OR an Associate of Science (AS) degree may be considered with extensive direct validation experience and demonstrated expertise in the field.

Knowledge, Skills & Abilities:

• Proven track record in laboratory instrument qualifications, with a preference for direct experience in ADC analytical processes.
• Deep understanding of regulatory requirements for the lifecycle management of analytical instrumentation and computer systems, including but not limited to current Good Manufacturing Practices (cGMP), 21 CFR Part 11, and Data Integrity principles.
• High level of professionalism and technical competency, with the ability to represent the validation department authoritatively in discussions with customers, regulatory bodies, and internal management.
• Solid grasp of global regulatory guidelines and standards affecting ADC manufacturing and quality control is essential. Should be capable of navigating and applying these regulations to ensure compliance across all validation activities.
• Exceptional project management capabilities are required, including the ability to lead projects, manage timelines, and coordinate cross-functional teams effectively. Outstanding communication and technical writing skills are crucial for documenting validation processes, preparing reports, and interacting with stakeholders, regulatory agencies, and management.
• Keen analytical mind, capable of identifying and solving complex technical problems, optimizing workflows, and contributing to continuous improvement initiatives.
• Ability to work flexibly and adaptively in a fast-paced and dynamic environment, prioritizing tasks and managing multiple projects simultaneously. A strong team player who contributes to a positive, team-based, and collaborative work setting, aligned with the organization's goals and values.
• Commitment to excellence and continuous improvement, with a working understanding of Six Sigma/Lean principles considered a plus. The candidate should demonstrate a continuous pursuit of quality, efficiency, and reliability in all aspects of work.
• This role demands a highly motivated and skilled individual who combines analytical expertise with regulatory knowledge and interpersonal skills to contribute significantly to our ADC facility's success.

Physical Requirements:

The position involves a dynamic range of physical activities. Candidates should be comfortable with frequent movements including lifting, bending, twisting, squatting, walking, and reaching. These motions are integral to the routine inspection, maintenance, and operation of laboratory instruments and equipment. Occasional lifting of items, not exceeding 50 pounds (approximately 23 kilograms), without assistance is part of the job requirements. This task may involve moving supplies or equipment necessary for laboratory operations or office functions.

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.