Scientific Lead for Monoclonal Antibody Development
6 days ago
Overview: We are seeking a highly skilled Scientific Lead to oversee the process development of monoclonal antibodies at our facility in San Francisco, CA.
About the Job:
As a Scientific Lead, you will be responsible for leading projects related to process and/or product development activities of monoclonal antibodies. Your primary focus will be on applying scientific principles and concepts to potential products and problems, while also interfacing with various internal and external teams. You will maintain broad knowledge of state-of-the-art principles and theories, and exercise judgment within broadly defined practices and policies in selecting and recommending new methods, techniques, and evaluation criteria for obtaining results throughout antibody production processes.
Key Responsibilities:
Design, develop, and support activities related to upstream/downstream process development and manufacture of monoclonal antibodies.
Lead multiple activities in parallel to drive project plans to completion, meeting project timelines and landmarks.
Review and approve technical protocols, reports, and GMP batch documentation.
Author and review regulatory sections in support of IND submissions.
Define complex problems, develop approaches, and develop experimental plans with sound judgment.
May independently represent the Company to outside organizations.
Requirements:
A PhD in a scientific or engineering discipline is required. Equivalent experience may be accepted. A minimum of 8 years work experience in a research and/or development environment focused on monoclonal antibody production is required. Post-doctoral work may serve as experience. Exceptional non-PhDs with demonstrated capabilities and/or significant experience across mAb upstream, downstream, and formulation development may also be considered. Must be able to demonstrate significant success in technical proficiency, scientific creativity, collaboration with others, and independent thought. Must be current and active in the field, while able to demonstrate expert knowledge in scientific principles and concepts both internally and externally with sustained performance and accomplishment. Must be able to clearly communicate scientific information both written and oral. Must be able to compose sound written work. Must possess good oral and written communication skills. Ability to present technical information to both technical and non-technical audiences is required. Must be able to demonstrate sound judgment. Must be able to demonstrate problem-solving capabilities. Experience working in an FDA regulated environment and knowledge of current GMPs is highly desired.
Compensation:
The salary for this position is approximately $140,000 per year, plus benefits.
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