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Scientist / Sr Scientist Cell Line Development

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AerotekBeltsville, MD
Full-time
  • The Scientist/ Senior Scientist in Cell Line and Cell Culture Process Development is expected to be a technical expert in cell sciences and provide hands-on technical leadership in designing, planning, execution, analysis and reporting of cell line development and cell culture process development studies to advance innovative biologics pipeline products.
  • The Scientist, either independently or in a team, would be responsible for utilizing advanced cell line development technologies, improving our current cell line development platform and developing highly productive manufacturing cell lines from DNA construct to cell banks for the company products.
  • He/She will utilize high-throughput clone screening and process development tools to evaluate cellular productivity, performance and production processes.
  • The Scientist/ Senior Scientist would be expected to make recommendations based on study results, scientific principles and industry best practices on clone selection and process design.
  • Plan and execute experiments using established practices and technologies to construct product specific clones from industry-standard mammalian host cell lines, evaluate clone performance, product quality, productivity and recommend primary clone.
  • Improve existing clone development and screening practices.
  • Evaluate and implement new technologies to significantly shorten construct to final clone timeline and probability of finding the most preferred clone.
  • Provide leadership for cell bank manufacturing and safety and genetic characterization studies working with a contract service providers and Quality Assurance.
  • Extensively utilize internal and external resources to perform media screening, process condition optimization and product quality evaluation.
  • Utilize scientific principles to scale-up from bench to pilot scale bioreactor.
  • Participate in internal clinical manufacturing as needed.
  • Utilize QbD principles and statistical methodologies to design and analyze development studies.
  • Author technical reports, participate in scientific presentations and seminars, present data and recommendations to senior management
  • Provide team leadership when appropriate, participate in Project Teams for the company's programs, and coach/mentor scientific staff
  • Required education and experience
  • Degree in Cell Biology, Molecular Biology, Biochemical/Chemical Engineering, Biochemistry, or other related field.
  • PhD with 3+ or Masters degree with 5+ or Bachelors degree with 8+ years industry experience
  • A strong understanding of the pharmaceutical/drug development process
  • Knowledge and application of CGMP principles and working in an FDregulated environment
  • Outstanding interpersonal, and leadership skills
  • Independent problem solving and systematic data-driven experimental design and execution
  • Good understanding of biochemical engineering mammalian cell biology and cellular pathways
  • In-depth hands-on experience of generating stable cell lines
  • Experience of designing and executing clone screening and process development studies using laboratory-scale cell culture systems and preferably high-throughput process development tools
  • Thorough understanding of mammalian cell culture-derived product characteristics and product quality
  • Innovative and analytical thinker
  • Ability to work under pressure and analyze processes within scheduled timeframes
  • Ability to work with cross-functional teams to support CMC development activities
  • Excellent organization skill
  • Strong written and verbal communication skills
  • Actalent connects passion with purpose.
  • Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more.
  • Every day, our experts around the globe are making an impact.
  • Were supporting critical initiatives in engineering and sciences that advance how companies serve the world.
  • Actalent promotes consultant care and engagement through experiences that enable continuous development.
  • Our people are the difference.
  • Actalent is an operating company of Allegis Group, the global leader in talent solutions.
  • The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

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