Serve as Process Sciences leader and subject matter expert in the development and characterization of purification processes for clinical- and commercial-stage manufacture of biopharmaceuticals.
Candidate will apply fundamental scientific principles to purification processes in-order to resolve processing issues, support process optimization and characterization, and evaluate process improvements, including changes in equipment, scale, and raw materials and aid in technology transfer.
Responsibilities will include providing technical leadership for cross-functional project teams, designing and executing lab experimentation, technical review of data, communication of work through oral presentations and authoring GMP documentation.
The candidate would be expected to keep current on the latest industrial, scientific and regulatory trends to assist in the review and authorship of relevant sections of global regulatory filings.
Manage and supervise a diverse team of process scientists and associates, including performance management, goal setting, overcoming obstacles and delivering results within project timelines.
Will be involved in project management of assigned projects, managing project resources (material, manpower, time, etc.), and elevating relevant issues to project lead and line-management.
Provide strong leadership of cross-functional teams to resolve complex problems while meeting quality, schedule, communication and cost objectives.
Evaluate and develop new technologies for incorporation into processes, equipment and operations.
Provide technical investigation support and proactively address process and raw material risks to ensure supply.
Build and maintain effective collaborations with diverse partner organizations across the Amgen network and with external suppliers.
Infrequent domestic and international travel may be required.
Doctorate degree and 2 years of directly related experience
Master’s degree and 6 years of directly related experience
Bachelor’s degree and 8 years of directly related experience
Associate’s degree and 10 years of directly related experience
High school diploma / GED and 12 years of directly related experience
Advanced degree in Life Sciences or Chemical Engineering
Ph. D. in Life Sciences, Chemical Engineering or related discipline with a downstream purification process development background.
Amgen - 9 months ago