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Process Development Associate

3 months ago


Thousand Oaks, United States The Steely Group Full time

The Pivotal Drug Substance Technologies organization develops, characterizes and supports clinical drug substance manufacturing processes for all late-stage programs in the company portfolio.


This lab-based position is located at the Thousand Oaks, CA site. The successful candidate will be responsible for support of the development, characterization, scale-up and support of upstream and downstream processes to enable clinical advancement of the programs.


This role is in an integrated bioprocess development group in which cell culture and purification scientists work together to advance the company's rich, exciting and dynamic pipeline. With the company's biology first approach, the position provides the unique opportunity to work on multiple modalities including antibodies, BiTEs, and bispecifics.


The successful candidate will design and execute experiments at the bench scale, spanning the end-to-end drug substance process, including both cell culture and purification operations. The candidate will apply established platform approaches and utilize problem-solving skills to rapidly solve day-to-day experimental challenges.


Additionally, the candidate will utilize out-of-the-box thinking to contribute to technology development, including process automation. Finally, the candidate will also expand and develop skills in both cell culture and purification, thereby further contributing to the integrated group.


Basic Qualifications:

  • Bachelor’s or master’s degree OR
  • Associate degree and 4 years scientific experience

Preferred Qualifications:

  • Master’s degree in Chemical Engineering, Biochemical Engineering, Life Sciences, or other relevant sciences with a demonstrated record of excellence.
  • Ability to identify, develop and implement solutions to practical problems through application of fundamental scientific and engineering principles, preferably in a process development environment.
  • Basic understanding of protein chromatography, filtration or cell culture principles; hands-on experience with mammalian cell culture, and/or purification operations is a plus.
  • Prior experience with data analytical tools (Excel, Spotfire, etc.) is preferred. Experience with statistical analysis and programming in JMP, R, and/or Python environments is a plus.
  • Motivated self-starter with excellent interpersonal and organizational skills.
  • Team player with the ability to successfully work within a diverse team in a dynamic, cross-functional environment.
  • Familiarity with design of experiments and statistical analysis of data desirable.