|Date Posted||December 2, 2020|
|Address||504 S Rosa Rd|
We are recruiting for a Sr. Research Specialist - Process Engineering to support our continued growth and on-going development projects. Qualified individuals need have the capability, and to be inspired to support the development of therapeutics (cGMP) products and tools to support research endeavors. We aspire to improve the quality of life through our efforts. In return we provide development and support to enhance your career using cutting edge iPSC technology.
In this hands-on laboratory role - you will focus on the scale-out, scale-up, optimization, and characterization of bio-processes for pluripotent stem cell expansion and directed differentiation of pluripotent cells to terminally differentiated cells. Design and execute experiments involving bioreactors, volume reduction technologies, and fill/finish operations. Write protocols and reports and contribute to the tech transfer of bio-processes to manufacturing.
In this role you will be responsible for the following:
Essential Job Functions
- Work with project team to develop robust bio-processes for manufacturing human induced pluripotent stem cell (iPSC)-derived products.
- Support the development, execution, and reporting of process optimization and characterization studies.
- Develop and document standard methods for cell processing unit operations including bioreactor-based cell culture, media manufacturing, cell washing and concentration.
- Write protocols, technical reports, and SOP's, and develop appropriate documentation for processes.
- Participate in technology transfer of processes to the manufacturing and quality control groups.
- Effectively communicate experimental results to the project team.
- Other job functions as assigned.
- Bachelor’s degree in chemical or bio-engineering, stem cell biology, cell biology, developmental biology, immunology or a closely related scientific field is required.
- Two years of relevant experience in cell culturing and bio-processing, with demonstrated achievements and progressive responsibilities
- Functional proficiency with cell culture and common cell biology assays (e.g., flow cytometry). medium to large scale (>3L) cell culture experience preferred.
- Demonstrated intellectual curiosity, work ethic, initiative, ability to multi-task, and a desire to acquire new technical skills.
- Demonstrated ability to change project objectives quickly and enthusiastically.
- Strong communication skills and demonstrated ability to work well independently and as part of a team and follow through on assignments with minimal direction
- Demonstrated ability to identify, troubleshoot and implement solutions to practical problems in a process development environment.
- Demonstrated ability to prioritize project objectives consistent with job function, and agreed upon timelines.
- Ability to work off-hours and on weekends as required.
- Able to work in laboratory hood and at computer for extended periods of time.
- Occasional lifting of up to 50 pounds.
- Able to work with hazardous materials (i.e. chemicals, electrical equipment and human tissue) without endangering oneself or others.
- Able to wear standard laboratory PPE.
- Preferred candidates with demonstrate the following:
- Experience with statistical Design of Experiments and/or Quality by Design
- Experience in process development as a member of product/process development teams
- Experience with cGMP biomanufacturing.
- Experience with pluripotent stem cells and/or differentiation.
- Various cell and molecular techniques including flow cytometry, Q-RT-PCR, fluorescence microscopy, and high content imaging