Engineer / Scientist, Manufacturing Science and Technology (MSAT)

Job Description

Job Description

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

Knowledge, Skills, Abilities

Physical Demands

Work Environment

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!