We are LOTTE BIOLOGICS ! Delivering 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, to reliably deliver benefits for patients worldwide.
Position Summary
The Engineer/Scientist, Manufacturing Science and Technology (MSAT) will report into the Development organization. The Engineer/Scientist will support upstream cell culture clinical manufacture of biopharmaceutical drug substance produced at the LOTTE Biologics Syracuse facility. The MSAT group supports a large-scale, cell culture, and purification facility. This position provides resolution of complex problems associated with manufacturing of biopharmaceutical drug substance and/or newer modalities. The Engineer/Scientist will contribute to a dynamic and highly collaborative team environment. The Engineer/Scientist will be required to work independently, with minimal 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.
Duties & Responsibilities
Troubleshoot process-related manufacturing issues on the floor by leveraging strong upstream and/or downstream process knowledge to ensure quality of the product and compliance according to regulations
Proactively identify and make formal 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 of process performance data/trends
Drive improvements to completion and provide regular data updates to management to track process performance
Use different data trending and statistical analysis tools to complete process review, modeling, principal component analysis, and multivariate analysis
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 authoring, review, and approval of manufacturing retrospective reports for inclusion in Annual Product Review(s) and Annual Quality Product Review(s), as applicable
Perform process facility fit, lead process technical transfers of new molecules and lead implementation of product/process transfers, including support of engineering, clinical, 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
Support and lead process development, process characterization, and process technical transfer activities from laboratory to manufacturing scales, including author/review of study protocols and final reports for studies required in Manufacturing, as applicable
Support and lead implementation of new technologies and procedures from Development into Manufacturing, as applicable
Support regulatory changes and filings through change control authorship and management, filing authoring and review, and data collection and analysis, as applicable
Review cGMP documentation including Standard Operating Procedures (SOPs) and Manufacturing Batch Records (MBRs), as required
Serve as designee for Manager as directed when training and qualifications are appropriate
Education & Experience
Degree in Biology, Chemistry, Biochemical or Chemical Engineering, or related industry experience: Minimum of a B.Sc/B.Eng with 6+ years, M.Sc./M.Eng degree with 4+ years, or Ph.D degree with no experience (0 years)
Knowledge, Skills, Abilities
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 must have demonstrated verbal, written, and communication skills including ability to present complex information clearly and concisely, with a successful proved history of working with technical teams
Experience should include technical support of a cGMP biologics manufacturing facility, including strong knowledge and engineering leadership for drug substance processing equipment, manufacturing support, and technology transfer
Prior experience in/knowledge of cell culture, recovery, and/or purification of biopharmaceutical drug substance in a manufacturing environment is required
Technical writing and data presentation abilities are requirements
Demonstrated leadership skills, and the 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 required
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
Target Bonus
10%
Work Location:
East Syracuse, NY
New York Pay Range
$76,000 - $113,000 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 to be a healthier place, then please apply today!
