AGC Biologics is a leading global Contract Development and Manufacturing Organization, with a deep commitment to improving life quality by bringing new biopharmaceuticals to market. Because of our dedication to building and empowering our internal teams, AGC Biologics is an innovative leader in the industry with an extensive network of cGMP facilities in the US, Europe and Asia. As such, we deliver a deep expertise, dynamic solutions and technologies, as well as customized services for the scale-up and cGMP manufacturing of protein-based therapeutics and cell and gene therapies. We forge exceptionally strong partnerships with our clients, and we never lose sight of our pledge to deliver a reliable and compliant drug substance supply, Right, On time. For more information, visit www.agcbio.com.

SUMMARY:

This is a Senior Development Scientist position in the Upstream Process Development group. Primary responsibilities include supporting the development, scale-up, and transfer of microbial cell culture processes to GMP manufacturing for the production of recombinant therapeutic proteins.

PRINCIPAL RESPONSIBILITIES:

  • Work with clients and internal project teams in the successful completion of contract manufacturing projects.
  • Coordinate bench scale experiments leading up to clinical and commercial manufacturing.
  • Proficiency in microbial cell culture and relevant lab methodologies. Trains other group members as needed.
  • Present data to project teams in verbal and written reports.
  • Take a leadership role within the department for developing and improving cell culture processes.
  • Develop, coordinate, and communicate experimental plans within the department.
  • Execute and manage shake flask and 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 operation of the lab and infrastructure improvements.
  • Provide technical support in the laboratory as necessary.
  • Troubleshooting 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.
  • Contribute to technology development—goal of increasing efficiency and productivity of manufacturing processes through cell culture media and process development.

KNOWLEDGE, SKILLS & ABILITIES:

  • Demonstrated experience in a mammalian cell culture and bioreactor lab environment.
  • Excellent technical writing and presentation skills.
  • Familiarity with fermenter/bioreactor controllers for bench scale and pilot scale production
  • Previous supervisory, technical guidance and leadership experience.
  • 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.
  • Experience with microbial fermentation late stage process development, small model qualification,
    and characterization work would be beneficial

EDUCATION/EXPERIENCE:

  • PhD (or equivalent experience) in life science or engineering with a minimum of 5-10 years of industrial experience in cell culture process development related to manufacturing biotherapeutics

 

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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