LOTTE BIOLOGICS USA, LLC
Engineer/Scientist, Manufacturing Science and Technology (MSAT)
LOTTE BIOLOGICS USA, LLC, Syracuse, New York, United States
Engineer/Scientist, Manufacturing Science and Technology (MSAT)
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 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 Travel: 5% travel required for this position. Work Location New York Pay Range $76,000 - $113,000 USD EEO We are an Equal Employment Opportunity (EEO) Employer.
#J-18808-Ljbffr
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 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 Travel: 5% travel required for this position. Work Location New York Pay Range $76,000 - $113,000 USD EEO We are an Equal Employment Opportunity (EEO) Employer.
#J-18808-Ljbffr