Engineer, ADC Technical Manufacturing

Lotte Biologics Usa • Syracuse, NY

9h • Hybrid

About The Position

LOTTE BIOLOGICS is seeking an ADC Technical Manufacturing Engineer to provide documentation, equipment, investigation, and process support to ADC Manufacturing. This role involves supporting process scale-up and transfers to ADC GMP manufacturing within a team-driven environment. The engineer will represent ADC Manufacturing on projects and cross-functional teams, provide training, and lead or participate in the implementation of new equipment and processes, Change Controls, BOMs, and SOPs/MBRs.

Requirements

• BS or MS degree in Biotechnology, Bio-Chemical Engineering, Biochemistry or related Life Science subject.
• 3+ years of experience as an engineer in the operation, design, construction and/or start-up of biopharmaceutical facilities (cGMP manufacturing plants, pilot plants, laboratories, etc.).
• Work experience with Antibody Drug Conjugates (ADCs) in the biotech/biopharma industry.
• In-depth knowledge and work experience of downstream processing techniques like chromatography and TFF.
• Strong technical operational knowledge of operational units such as tangential flow filtration, dead-end filtration, protein chromatography, and conjugation reactions.
• Knowledge of HiPo material handling and environmental safety awareness.
• Strong understanding of cGMP and regulatory agency requirements.
• Demonstrated experience in solving complex technical issues in Biologics/ADC manufacturing.
• Possess the skills and understanding to troubleshoot process equipment and the overall manufacturing process.
• Demonstration of successful participation on diverse work teams where combined contribution, collaboration and results were expected.
• Excellent written and verbal skills and the ability to provide direction and communicate expectations to the operating staff.
• Strong computer skills and proficient in Microsoft Office Suite.
• Ability to work off-hours as needed to complete projects or key tasks requiring SME oversight.
• Adaptable to a fast-paced, complex and ever-changing business environment.
• Proficient in the following programs: Word, Excel, and Visio.

Responsibilities

• Lead large scale manufacturing operational and equipment improvement initiatives from conception to implementation to improve cadence, simplify operations, and enhance compliance.
• Represent ADC Manufacturing Operations on projects and initiatives.
• Support MFG shift operations, Tech Transfers, Process Improvements, and other teams as required.
• Adhere to all plant safety policies and procedures and proactively identify unsafe conditions.
• Authoring of equipment and facility change controls, MBR revisions, and CAPA Action Plans.
• Process and equipment support and troubleshooting.
• Author, revise, and approve critical Manufacturing documentation, including MBRs, BOMs, and SOPs.
• Development and execution of training materials for new processes and equipment in conjunction with the site technical training team.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level