Duties:

This position will work on the process development of monoclonal antibodies to be used for clinical study involving complex problems in which analysis of situations or data requires an in-depth evaluation of various factors and contributes to and supports the company’s research and development efforts to create high value therapeutics to address unmet medical needs.

Leads projects related to the execution of process and/or product development activities of monoclonal antibodies and participates in planning and strategy.

Applies scientific principles and concepts to potential products and problems.

Interfaces with various internal and external teams.

Maintains broad knowledge of state-of-the-art principles and theories.

Education:

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 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.

Languages:

English( Speak, Read, Write )

Skills:

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.

Defines complex problems, develops approaches and develops experimental plans with sound judgment.

Exercises judgment within broadly defined practices and policies in selecting, and may recommend new methods, techniques and evaluation criteria for obtaining results throughout antibody production processes.

May independently represent the Company to outside organizations.

Minimum Degree Required: Doctor of Philosophy (Ph. D.)

City: San Francisco