Engineer, ADC Technical Manufacturing
About The Position
LOTTE BIOLOGICS is a new company, built on 80 years of tradition, dedicated to delivering therapies that enable a healthier world. We embody 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. The primary role of the ADC Technical Manufacturing 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 ADC Technical Manufacturing Engineer will be the ADC Manufacturing representative on various projects and cross-functional teams, will provide training, participate and/or lead in the implementation of new equipment and processes, Change Controls, BOM, and SOP/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 oversite.
- Adaptable to a fast-paced, complex and ever-changing business environment.
- The candidate will have strong computer skills and be proficient in the following programs: Word, Excel, and Visio.
- The position requires the ability to work off-hours as needed to complete projects or key tasks requiring SME oversite.
Responsibilities
- 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 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; i.e. MBRs, BOM, and SOPs.
- Development and execution of training materials for new processes and equipment in conjunction with the site technical training team.
Benefits
- Target Bonus 8%
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
