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 an Associate Engineer/Scientist, Manufacturing Technology in our Manufacturing Sciences & Technology organization. The Associate Engineer/Scientist will support upstream cell culture and downstream purification commercial manufacture of biopharmaceutical drug substance produced at the LOTTE BIOLOGICS Syracuse Bio Campus. The Manufacturing Technology group supports a large-scale, cell culture, and purification facility. This position will provide resolution of complex problems associated with manufacturing of biopharmaceutical drug substance and/or newer modalities with support of management. The Associate Scientist will contribute to a dynamic and highly collaborative team environment. The Associate Scientist will work with supervision to develop and deliver on appropriate objectives and priorities, overcome obstacles, and deliver results within established timelines. This position is a team-based position that may require work on evenings, weekends, and holidays.
- Troubleshoot process-related manufacturing issues on the floor by leveraging upstream and/or downstream process knowledge while working with supervision to ensure quality of the product and compliance according to regulations
- Proactively identify and make recommendations for opportunities to improve process performance, productivity, robustness, quality, business process, and safety through on-floor observation and through active collection, routine process and data monitoring/review, and statistical analysis tools to evaluate process performance data/trends
- Drive improvements to completion and provide regular process performance tracking updates to supervision
- Author process-related Change Controls and applicable effectiveness checks
- Author Quality Events (QEs) with a view toward providing thorough root cause analysis, making a product impact assessment, and provide recommendations for effective Corrective Action and Preventive Action (CAPA)
- Support continued process verification program activities including authoring process monitoring plans, leading statistical alert event investigations, out-of-tolerance events, and support data lifecycle activities for internal and client needs, as applicable
- Support data requests, authoring, review, and approval of manufacturing retrospective reports for inclusion in Annual Product Review(s) and Annual Quality Product Review(s), as applicable
- Support process facility fit, process technical transfers of new molecules and implementation of product/process transfers, including support of engineering and process validation (PV) studies, as appropriate
- Author technical documents and whitepapers, risk and impact assessments, Process Performance Qualification (PPQ) protocols and reports, provide floor coverage support for critical operations, and ensure that PV samples are collected and submitted with support from supervision
- Work with supervision to support process development, process characterization, process technical transfer activities, and implementation of new technologies from laboratory to manufacturing scales, including author/review of study protocols and final reports for studies required in Manufacturing, as applicable
- Support regulatory changes and filings with supervision to include change control authorship and management, data collection, as well as filing authoring, verification, and review
- Review cGMP documentation including Standard Operating Procedures (SOPs) and Manufacturing Batch Records (MBRs), as required
Remote Position:falseMin Compensation :USD $60,000.00/Yr.Max Compensation :USD $88,000.00/Yr.Bonus:8%Qualifications:
Education/Experience:
- Degree in Biology, Chemistry, Biochemical or Chemical Engineering, or equivalent area of related industry experience in biologics upstream and/or downstream manufacturing or manufacturing technology: B.Sc/B.Eng with 3-5 years or M.Sc./M.Eng degree with 0-2 years
- Prior experience with technical support of cGMP/Biologics manufacturing facility and/or cGMP investigations (R&D, technology transfer, manufacturing) is preferred
- Prior experience in or knowledge of cell culture, recovery, and/or purification of biopharmaceutical drug substance in a manufacturing environment is preferred
- The candidate should have demonstrated verbal, written, and communication skills
- Technical writing and data presentation abilities are preferred
- Technical support of a cGMP biologics manufacturing facility, including strong knowledge and engineering leadership for drug substance processing equipment, manufacturing support, and technology transfer is preferred
- Prior experience in/knowledge of cell culture, recovery, and/or purification of biopharmaceutical drug substance in a manufacturing environment is preferred
- Demonstrated ability to interact with diverse groups and teams is preferred
- Project management skills (organization, collaboration, multi-tasking and communication), attention to detail, and the ability to perform well in a team-based environment is preferred
- Prior experience in leading cGMP investigations using formal Root Cause Analysis tools is preferred
- Prior experience with SOPs, cGMPs, and the know-how to work within a regulatory environment is preferred
- Prior experience facilitating/participating in Risk Assessments is preferred
Physical Demands:
- Position requires repetitive use of hands and wrist (computer work), and infrequent lifting of items not to exceed 50 lbs
- Occasional bending, twisting and stooping to allow for gowning into classified environment is required
Work Environment:
- Position is primarily office based with occasional work in a classified GMP manufacturing environment
- Position is a team & project-based position that will require occasional shift work, weekends, and holidays
Travel:
This position requires up to 5% of domestic and/or international travel.
Supervisory Responsibilities:
The position may manage one to two contingent workers on the team. The position may be responsible for deliverables of this team and must also lead the safety culture of the team.
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:
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 Squibbs 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.