The Cell Culture and Fermentation Sciences Group is accountable for cell line development, process development, and process characterization. This group assists in the scale up and technical transfer of processes to different clinical and commercial sites and also supports manufacturing deviations and regulatory submissions as needed.

Main Duties & Responsibilities:

The Senior Scientist role is to develop and optimize upstream biological production processes using fed-batch or perfusion modes. This position may require weekend work. Major duties and responsibilities include:

• Represent Cell Culture function on project teams in development of pipeline assets

• Develop robust upstream manufacturing processes, including cell expansion development for various cell lines through design and execution of experiments in shake flasks or small-scale bioreactors to optimize process performance for recombinant protein production

• Develop new methods, tools and processes as required to support process development efforts.

• Prepare technical reports, experimental protocols, and technical summaries for presentation as well as participation in the technology transfer of processes into cGMP production facilities and filing regulatory submissions

• Independently make detailed observations, formulate hypotheses, analyze data, interpret results, and exercise appropriate technical discretion in the design, execution, and interpretation of experimental results presented internally and externally

• Must be able to work in a team-based structure and interface with research and process development departments effectively in a fast-paced environment while understanding and adhering to relevant Safety, Health and Environment (SHE) standards

• Education:  Bachelor’s, Master’s, or PhD in Chemical/Biochemical/Biomedical Engineering, Biotechnology, Biochemistry, Cell Biology, Biological Sciences or related field

   Experience: BS and 10+ years, MS and 8+ years, or PhD and 0+ years of relevant experience

• Proficient in a laboratory environment

• Knowledge of design of experiment (DOE) and statistical analysis tools such as JMP

• Solid understanding of biochemical engineering concepts and biochemical pathways

• Solid knowledge of mammalian cell culture and aseptic techniques including “hands-on” working experience with fermentors/bioreactors in the development and optimization of cell culture processes

• Proficiency in Microsoft Office (or related) programs

• Must be able to generate complete and concise written documentation and presentations with little supervision and be able to present data in a clear and concise manner to various teams

• Excellent communication skills, with the ability to collaborate with colleagues in a cross-functional, fast paced team environment

Desired skills:

• Knowledge of Scale-Up/Scale-Down Principles

• Experience using ambr15/250 or similar high throughput tools

• Experience in single-use and perfusion technologies

• Experience and/or working knowledge of recovery and clarification techniques, familiarity with Protein Purification process development

• Experience with media development/optimization

• Molecular/Cell biology skills such as mammalian cell transfection, PCR, Western Blot or Flow Cytometry