Associate Scientist, Purification Process Development
Key Accountabilities / Core Job Responsibilities
- Support purification process characterization, validation, PPQ and BLA-enabling activities.
- Monitor process performance, trend data, and coordinate sample handling from GMP manufacturing campaigns.
- Extract and organize data for report and submission authoring and contribute to statistical analysis.
- Support tech transfer for and GMP campaign readiness.
- Execute lab-scale chromatography and filtration studies to inform late-stage data packages.
- Execute in-process testing using ELISA, HPLC, UV and SDS-Page based analytics.
- Summarize key experimental data and document experiments in an electronic lab notebook.
- Collaborate with colleagues in CMC, Discovery and other functions to achieve project goals.
Requirements
- BS/MS in Biology, Biochemistry, Chemical Engineering or related scientific discipline with 3+ years of industry experience.
- Experience in protein characterization, design of experiments and analytics.
- Experience monitoring downstream GMP and/or pilot production unit operations.
- Hands-on experience with AKTA protein purification systems, lab-scale TFF systems and antibody characterization methods including HPLC, LC/MS, SDS-PAGE, DLS and other biophysical techniques.
- Excellent critical thinking, scientific problem-solving and communication skills.
- Prior experience in a late-stage process development setting preferred.
Benefits
- Competitive total rewards package including 401k, healthcare coverage, ESPP, and other benefits.
Application Instructions
- Learn more at https://www.denalitherapeutics.com/careers