Regulatory Operations SpecialistJanuary 7, 2018
We are looking for a driven independent thinker with a monster work ethic that shares our long‐term vision for a donor‐independent blood system. Initiative and creative problem solving are priorities since you’ll be partnering with us to fundamentally disrupt a firmly established industry. We seek a highly motivated, versatile process development scientist or engineer (Ph.D. or M.S. with equivalent relevant industry experience) to help develop a scalable culture process for our human iPSC to megakaryocyte differentiation cultures.
Duties and Responsibilities
Job responsibilities include testing proprietary and commercially available cell culture bioreactors, process optimization and robustness in support of commercial manufacturing productions, and working closely with Contract Research Organizations supporting our process development. Primary duties will include but not limited to:
- Lead, design and execution of process development and technical support activities for upstream process from clinical process development to licensure and commercial manufacturing
- Generate, manage, analyze, and maintain critical data in a highly organized manner
- Authoring/reviewing development reports, process transmittals, and manufacturing records
- Coordination and interfacing with colleagues from other groups involved in the research process, including cell line development, bioreactor scale-up, functional assessment, manufacturing for clinical trial purposes.
- Active involvement in technology transfer via written process transmittals, and by providing troubleshooting, process understanding, and on-site support to manufacturing production campaigns.
- Some local or regional travel may be expected.
Daily tasks will include (but are not limited to):
- Cell cultivation in shaker flasks and bioreactors
- Benchtop bioreactor operation and maintenance
- Media and reagent preparation
- Supervision of research associates and/or interns
- Authorized to work in the U.S. – Required.
- PhD, or MS with related bioprocess expertise.
- Experience with mammalian cell culture, microscopy, and flow cytometry
- Experience with fed-batch bioreactor processes including optimizing, feeding strategies, and evaluating different cell culture media and feed formulations
- Experience with human pluripotent stem cells and/or hematopoietic differentiation
- Critical thinker with excellent problem‐solving skills
- Excellent written and verbal communication skills
- Strong interpersonal skills and an ability to work well both in a team and independently
- Skilled presenter able to deliver technical summaries of data as well as high level explanations designed to support strategic decisions
- Ability to multi‐task efficiently and work under pressure with precision
- Experience with training laboratory staff at various levels
- Willingness to go above and beyond job requirements when necessary
Additional Skills (preferred, but not required):
- Experience with statistical design and analysis software (i.e. JMP)
- Familiarity with computer programming languages (i.e. VBA/VB .Net, HTML, C++), relational database interface/design and SQL, networking interactions, and software installation/troubleshooting
Please send cover letter and CV/resume to: