Process Development Scientist I/II

14 hours ago

København, Denmark AGC Inc Full time
Process Development Scientist I/II

Apply locations Bothell, Washington, USA
Time type Full time
Posted on Posted 3 Days Ago
Time left to apply End Date: January 31, 2025 (30+ days left to apply)
Job requisition id JR101310

Our purpose is to bring hope to life by enabling life-changing therapies for patients around the globe, creating a healthier and happier tomorrow. Our mission is to work side by side with our customers in order to improve patients’ lives by bringing new biopharmaceuticals to market.

SUMMARY:

This is a Process Development Scientist I/II position in the Cell Line Development/ Upstream Process Development (CLD/ UPD) group. Primary responsibilities include designing and executing various CLD platform improvement and technology development projects, acting as a CLD Subject Matter Expert (SME) in internal and external meetings, and supporting the development, scale-up, and transfer of mammalian cell culture processes to GMP manufacturing for the production of recombinant therapeutic proteins.

RESPONSIBILITIES:

  • Design, write protocols, execute, and analyze experiments to improve the current CLD platform and evaluate new CLD technology with a goal to enhance cell productivity while ensuring scalability and robustness of manufacturing processes.
  • Present data to project teams in verbal and written formal reports.
  • Work with clients and internal project teams in the successful completion of contract manufacturing projects.
  • Take a leadership role within the department in developing and improving cell culture processes:
    • Develop, coordinate, and communicate experimental plans within the department.
    • Execute and manage shake flask and/or bench scale bioreactor experiments.
    • Manage large data sets and provide technical guidance to others in the analysis and interpretation of data.
    • Write development protocols and characterization reports.
    • Coordinate activities and experiments with project management, manufacturing, purification development, and analytical development.
    • Provide technical support to manufacturing during large-scale manufacturing campaigns.
  • Contribute to the overall CLD lab operations and infrastructure improvements:
    • Perform molecular cloning, DNA purification, transfections, cell passaging, cell imaging, monoclonality determination, cell thaw, and cryopreservation, fed-batch production in shake flasks and bioreactors, and periodic lab maintenance tasks.
    • Perform titer analysis by Octet or other assays as needed.
    • Provide technical support in the laboratory as necessary.
    • Troubleshoot process control instrumentation.
    • Implementation of new equipment and technology.
  • Provide technical and strategic planning support to business development activities with respect to new client projects and new business initiatives.

KNOWLEDGE, SKILLS & ABILITIES:

  • Demonstrated experience in expression vector optimization, cell line engineering, media optimization, and other CLD platform improvements.
  • Excellent technical writing and presentation skills.
  • Ability to problem solve and troubleshoot.
  • Flexibility to work both independently and in a team setting.
  • Willingness to support evening or weekend work, if needed.
  • Ability to lift 30 pounds and good manual dexterity to work in a laboratory environment.
  • Must be dependable, detail-oriented, organized, and willing to perform both routine tasks and develop new skills.
  • Previous supervisory, technical guidance, and leadership experience is preferred.
  • Entrepreneurial/business aptitude with interest in growing a contract manufacturing business.
  • Good interpersonal relationship skills required for working with clients.
  • Previous experience with process validation activities and knowledge of large-scale manufacturing activities in a GMP environment.
  • Experience with JMP or other statistical analysis tools would be beneficial.

EDUCATION/EXPERIENCE:

  • An advanced degree in life science or engineering: Master’s with a minimum of 8 years or Ph.D. with a minimum of 3 years of industrial experience in mammalian cell line development related to manufacturing biotherapeutics.

COMPENSATION RANGE:

Based on experience:

  • Process Development Scientist I - $94,000 to $129,250
  • Process Development Scientist II - $108,080 - $148,610

AGC Biologics offers a highly competitive compensation package and a friendly, collaborative culture that values personal initiative and professional achievement. AGC Biologics is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, ancestry, color, family or medical care leave, gender identity or expression, genetic information, marital status, medical condition, national origin, physical or mental disability, political affiliation, protected veteran status, race, religion, sexual orientation, or any other characteristic protected by applicable laws, regulations and ordinances.

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