Arbutus has an opportunity for a Senior Scientist in Process Chemistry to join our growing team in Warminster, PA. Reporting to the Director in Process Chemistry, the Senior Scientist, Process Chemistry will provide scientific leadership in the small molecule process research and development. The individual will be expected to perform hands-on laboratory research, communicate results in both written and oral forms as well as present updates of the performed work at team meetings.
Responsibilities will include:
• Deliver on research and development goals and objectives.
• Apply expert knowledge to proposed research and development projects, including exploratory and formal research/development programs.
• Perform route scouting, identify scalable syntheses and develop manufacturing processes for APIs and intermediates.
• Participate in technology transfer, support cGMP manufacturing batch record reviews, discrepancy resolution (e.g. deviation investigations), person-in-plant support, and troubleshooting during manufacturing at contract manufacturing organizations (CMO’s).
• Capable of performing risk assessments, design/execute experiments, gain process knowledge to develop robust manufacturing processes for APIs.
• Develop control strategies based on development studies and manufacturing experience.
• Apply Quality-by-Design (QbD) concepts during process development and manufacturing of APIs.
• Coordinate interdisciplinary resources in collaboration with the research and development teams and line management.
• Serve as representative on a project team as project leader..
• Identify and manage external collaborating parties and/or contract research laboratories performing studies on behalf of Arbutus.
• Maintain knowledge of published developments in research field; recommend alternative approaches to research and development programs.
• Foster a spirit of cooperation, teamwork and motivation within the laboratory and department.
• Present scientific results in a variety of settings, both within and outside of the company.
• Contribute to the development of Arbutus patent portfolio and the scientific literature.
• Mentor and manage junior staff as required; provide scientific leadership in a matrix team environment.
• Other duties as required.
• Ph.D. in Chemistry and minimum 4 years relevant experience in the biotech / pharmaceutical industry or equivalent combination of education and experience with a proven record of accomplishment in the field.
• Recognized as an expert in the small molecule process research and development with documented accomplishments in publications and presentations.
• In depth knowledge in of applicable ICH / regulatory requirements, cGMP manufacturing, process research and development, technology transfers, troubleshooting, risk assessments, and Quality-by-Design (QbD) concepts.
• Prior experience supporting GMP manufacturing (in-house) or working with CMO’s is preferred.
• Excellent verbal and written communication and presentation skills.
• Able to effectively present to a variety of internal and external audiences.
• Able to collaborate and influence others at all levels throughout a diverse organization.
• Ability to manage deadlines and prioritize effectively, while maintaining flexibility and able to achieve team/extended team buy-in
• Demonstrates scientific creativity, works independently and takes initiative.
• Proven ability to manage and motivate scientific teams.
• Prior experience in effectively leading research and development projects from the bench is essential.
• Has made substantial contributions to one or more drug development programs.
*No agency calls will be accepted.