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Senior Associate Scientist - Cellular Process Development

Company: Kelly Services
Location: Cambridge
Posted on: April 9, 2021

Job Description:

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 environment----Highlights:

  • 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 workstreams.
  • Provide critical lab support while working in a collaborative team environment.
  • Hands-on lab-based position (50%) that may require a flexible schedule based on experimental work (occasional weekend work may be required).----Qualifications:
    • 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 (MS).
    • 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 desirable.
    • 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 fashion.
    • 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 problem-solving ability.
    • 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 Law.]]

Keywords: Kelly Services, Cambridge , Senior Associate Scientist - Cellular Process Development, Other , Cambridge, Massachusetts

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