Scientist/Engineer, Manufacturing Technology - LOTTE BIOLOGICS USA, LLC

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.

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

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
• 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

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%