Job: Process Development Scientist I-Upstream, KBI Biopharma, Durham, NC
Supports upstream cell culture development efforts in the development and manufacturing areas. Conceptualizes, proposes and executes process development studies for client projects, primarily for mammalian cell culture. Includes experimental design, set-up, maintenance and harvest of shake flasks, bench-scale bioreactors and 50 L and 200 L single-use bioreactors (SUBs).
Technical transfer of upstream cell culture processes to manufacturing based on development studies. May provide technical support for cGMP manufacturing.
Responsible for producing high quality documentation and client reports suitable for publication and regulatory requirements.
Works toward developing a broad knowledge of state of the art principles and theory; may provide technical leadership in the group, lead in-house technical development projects and may serve as in-house advisor on key scientific discipline areas.
May be called upon to be a project team leader of a development program that includes the following duties:
Direction and administrative duties including the coordination of efforts of team members and across departments; Acting as spokesperson on development programs and interact positively and productively with clients; Advising management on program status.
Responsible for developing/maintaining a current understanding of cGMP and other regulatory requirements.
Adheres to all safety requirements and assures that departmental employees comply with required safety procedures.
Able to react to change productively and handle other essential tasks as assigned.
B.S. degree and 9 years of related experience; M.S. and 7 years of related experience or Ph.D. and 2+ years related experience in a scientific discipline.
Ability to work independently.
Excellent organization and planning skills.
Skilled in Excel data entry, plotting, preparing reports and presentations.
Experience with cell culture aseptic technique required.
Experience with bench- and pilot-scale cell culture bioreactors preferred.
Excellent customer service skills and the ability to meet strict client deadlines.
Flexibility of hours to support cell culture and fermentation processes including weekend work
KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its work force. Therefore, all qualified applicants, regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability or Vietnam veteran status, are strongly encouraged to apply.