Senior Associate Scientist - Cellular Process Development
Company: Kelly Services
Posted on: April 9, 2021
Cellular Process Development Senior Associate Scientist
I/IICambridge, MADirect Hire/Salaried--The cellular process
development team is responsible for developing cellular drug
product processes and introducing new technologies for stem cell
therapies. We are looking for a motivated scientist with the
experience and drive to take ownership of important development,
characterization, and process improvement projects. You will
utilize your experience in a variety of cell-based methods and a
strong understanding of tissue culture, cell biology, immunoassays,
and general laboratory techniques, as well as pertinent experience
in the transfer and application of technology in a cGMP
- Contribute to the development and characterization of
engineered hematopoietic stem cell (HSC) processes to support
manufacturing of both early and late stage products.
- Work collaboratively with members from other groups including
cell research, analytics, quality, and regulatory functions.
- Develop experimental plans, author protocols and reports,
interpret scientific results, and support CMC activities.
- Summarize and present scientific data to stakeholders.
- Develop process improvements for unit operations for HSC-based
clinical and commercial programs.
- Independently manage and execute on key project
- Provide critical lab support while working in a collaborative
- Hands-on lab-based position (50%) that may require a flexible
schedule based on experimental work (occasional weekend work may be
- BS/MS in molecular biology, cell biology, biomedical
engineering, chemical engineering, bioengineering, biochemistry or
related degree with 4+ years of industry experience or relevant
academic experience (BS) or 1+ years of industry experience
- Experience authoring technical protocols, reports, and/or
regulatory filing sections is required.
- Expertise in aseptic tissue/cell culture is required.
Experience with the culturing of primary human hematopoietic stem
cells is preferred.
- Familiarity with designing and characterizing processes by
applying Quality by Design principles is preferred.
- Strong background in a variety of biological assays including
FACS and qPCR is preferred.
- Experience with large scale, closed system manufacturing of
therapeutic cell and/or gene therapy products from whole blood,
apheresis, or bone marrow is highly preferred.
- Familiarity with common cellular therapy equipment such as
Sepax, controlled rate freezers, and cell separation technologies
(CliniMACS and other technologies) is preferred.
- Demonstrated experience with DOE models and background in using
statistical software (JMP, Minitab, Prism or others) is
- Experience with risk-based assessments such as RCA, FMEA, and
streamlining processes is preferred.
- Ability to manage priorities and make decisions in a fast-paced
environment to ensure deliverables are completed in a timely
- Ability to work effectively in a collaborative team environment
where results are achieved through influence, cooperation, and the
incorporation of multiple points of view.
- Independently motivated, detail oriented and excellent
- Excellent organizational skills, with an ability to embrace
change and multi-task in an extremely fast-paced environment.
- Excellent communications skills and ability to influence across
multiple functions.Why Kelly--?Kelly Science & Clinical is your
connection to premier scientific and clinical companies looking to
hire talented people just like you. Every day, we match science
professionals with dream jobs that fit their skills and
interests-it's the way we think job searching should be. Nearly 100
percent of our science recruiters have a professional
background/education in science, so we know a thing or two about
the science market and how to get you noticed.About Kelly--At
Kelly, we're always thinking about what's next and advising job
seekers on new ways of working to reach their full potential. In
fact, we're a leading advocate for temporary/nontraditional
workstyles, because we believe they allow flexibility and
tremendous growth opportunities that enable a better way to work
and live. Connecting great people with great companies is what we
do best, and our employment opportunities span a wide variety of
workstyles, skill levels, and industries around the world. Kelly is
an equal opportunity employer committed to employing a diverse
workforce, including, but not limited to, minorities, females,
individuals with disabilities, protected veterans, sexual
orientation, gender identity. Equal Employment Opportunity is The
Keywords: Kelly Services, Cambridge , Senior Associate Scientist - Cellular Process Development, Other , Cambridge, Massachusetts
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