KBI Biopharma Scientist II - Upstream Process Development in Boulder, Colorado
Executes process characterization, technology transfer to commercial cGMPfacility, and process performance qualification activities.Responsible for producing high quality documentation and client reportssuitable for publication and regulatory requirements.Works toward developing a broad knowledge of state of the art principles andtheory; may provide technical leadership in the group, may serve asin-house advisor on key scientific discipline areas.Supports process development efforts in the laboratory and manufacturingareas. Executes experiments with minimal oversight. Conceptualizes andproposes process development and manufacturing based on process data.May lead either the upstream or downstream portion of development, processcharacterization, and/or technology transfer programs, acting as subjectmatter expert, and directing the efforts of the team in meeting the projectdeliverables.Provide technical support for cGMP manufacturing through floor coverage,batch document review, and support of deviations and change controls withminimal oversight.May be called upon (as a development assignment) to be a project teamleader of a development program that includes the following duties:Direction and administrative duties including the coordination of efforts ofteam members and across departmentsActing as spokesperson on development programs and interact positively andproductively with clientsAdvising management on program status.Responsible for developing/maintaining a current understanding of cGMP andother regulatory requirements.Adheres to all safety requirements and assures that departmental employeescomply with required safety procedures.Able to react to change productively and handle other essential tasks asassigned.Experience:B.S. degree and 9 years of related experience; M.S. and 7 years of relatedexperience or Ph.D. and 2+ years related experience in a scientificdiscipline.KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversifyits work force. Therefore, all qualified applicants, regardlessof race, color, national origin, religion, gender, genderidentity, sexual orientation, age, disability or veteran status, arestrongly encouraged to apply.