Engineer, ADC Technical Manufacturing

Associate Engineer, ADC Technical Manufacturing

LOTTE BIOLOGICS delivers therapies that enable a healthier world. 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, reliably delivering benefits for patients worldwide.

The primary role of the ADC Technical Manufacturing Associate Engineer is to provide documentation, equipment, investigation, and process support to ADC Manufacturing. This individual will work in a team-driven environment to support process scale‑up and process transfers to ADC GMP manufacturing. The Associate Engineer will be the ADC Manufacturing representative on various projects and cross‑functional teams, provide training, participate in and/or lead the implementation of new equipment and processes, change controls, BOM, and SOP/MBRs.

• Lead large‑scale manufacturing operational and equipment improvement initiatives from conception to implementation in order to improve cadence, simplify operation and improve compliance.
• Represent ADC Manufacturing Operations on projects and initiatives.
• Support shift operations, tech transfers, process improvements, and other teams as required.
• Adhere to all plant safety policies and procedures and proactively identify unsafe conditions.
• Author equipment and facility change controls, M  revisions, and CAPA action plans.
• Provide process and equipment support and troubleshooting.
• Author, revise and approve critical manufacturing documentation such as MBRs, BOMs, and SOPs.
• Develop and execute training materials for new processes and equipment in conjunction with the site technical training team.

• 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 startup 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 of downstream processing techniques such as chromatography and TFF.

• Strong technical operational knowledge of 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 solving complex technical issues in biologics/ADC manufacturing.
• Skill in troubleshooting process equipment and overall manufacturing process.
• Successful participation on diverse work teams with collaboration and results.
• Excellent written and verbal communication skills and ability to provide direction and communicate expectations to operating staff.
• Strong computer skills with 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.

• Repetitive use of hands and wrists (computer work); occasional lifting of items not to exceed 50 lbs.; bending, twisting and stooping for gowning in classified environments.
• Primarily office‑based with occasional work in a classified GMP manufacturing environment.
• Occasional shift work, weekends and holidays.

5-8% travel required.

New York, Pay range: $60,000 - $88,000 USD.

We are an Equal Employment Opportunity (“EEO”) Employer. 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 healthier, please apply today!