Scientist/Engineer, Manufacturing Technology

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 Scientist/Engineer, Manufacturing Technology, will support upstream cell culture and downstream purification commercial manufacture of biopharmaceutical drug substance produced at the LOTTE BIOLOGICS Syracuse facility. This position reports to the Senior Principal Scientist/Principal Scientist of Manufacturing Technology.

The Manufacturing Technology 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 Scientist/Engineer will contribute to a dynamic and highly collaborative team environment. The Scientist/Engineer 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.

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)

Perform process facility fit, lead process technical transfers of new molecules and lead 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

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)

Prior experience with technical support of cGMP/Biologics manufacturing facility and/or cGMP investigations (R&D, technology transfer, manufacturing) is required

Prior experience in or knowledge of cell culture, recovery, and/or purification of biopharmaceutical drug substance in a manufacturing environment is required

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

Knowledge, Skills, Abilities

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

Demonstrated technical writing and data presentation abilities

Demonstrated leadership skills, and the ability to interact with diverse groups and teams

Project management skills (organization, collaboration, multi-tasking and communication), attention to detail, and the ability to perform well in a team-based environment

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

Supervisory Responsibilities

The position may manage one to four contingent workers, as well as other positions on the team. The position will be responsible for development of this team and must also lead the safety culture of the team.

Travel

This position may require up to 5% travel

Target Bonus

10%

New York Pay Range

$76,000—$113,000 USD

We are an Equal Employment Opportunity ("EEO") Employer.

Full-time