Regulatory Operations SpecialistJanuary 7, 2018
Scientist / Sr. Research Scientist – Bioconjugation / Drug DeliveryFebruary 28, 2018
We are looking for a driven independent thinker with a monster work ethic who shares our long‐term vision for leveraging Mother Nature’s drug delivery system to cure diseases. Initiative and creative problem solving are priorities!
Duties and Responsibilities
Because we are a startup, the position calls for duties that are broad and variable, with significant opportunity for advancement. Specifically, you will be responsible for:
- Lead, design and execute process development and optimization 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.
- Benchwork in Cell cultivation in shaker flasks and bioreactors, bioreactor operations and maintenance, and media and reagent preparation.
- Author/review development reports, process transmittals, and manufacturing records
- Coordinate and interface 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.
- Leading the development of a scalable process.
- Interacting and working closely with Contract Research and Medical Organizations supporting our process development.
- Some local, regional, and/or international travel may be expected (<10%).
- Authorized to work in the U.S. – Required.
- PhD, with a minimum of 5 years relevant industry experience, or M.S. with 10 years relevant industry experience.
- Experience with mammalian cell culture, microscopy, and flow cytometry.
- Experience with fed-batch and perfusion-based 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 and supervising laboratory staff at various levels.
- Willingness to go above and beyond job requirements when necessary.
Additional Skills (preferred, but not required):
- PhD, with 5+ years relevant industry experience, or M.S. with 10+ years relevant industry experience.
- 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: