Title: Sr. Scientist– Downstream Process Development
Location: Carlsbad, CA
Duration: 6 months+ Temp-to-perm potential (never guaranteed)
Pay Range: $50-$70 (offer will depend on experience level)
8am-5pm – need flex for OT and some weekend work
100% on-site
Must have:

• Bachelors Degree in Chemical Engineering/ Biochemistry preferred
• Early/late stage process development experience
• Chromatography experience

What will this person be responsible for day-to-day?

• Preparation and execution of process development experiments (chromatography, normal flow filtration, and tangential flow filtration).
• Planning and execution of experiments successfully with minimal supervision.
• Good documentation skills in notebooks and/or worksheets.
• Data entry and analysis, more senior candidates should have experience with statistical analysis and interpretation of data.
• Expected to modify worksheets, design experiments with minimal direction, and handle scale-up activities.

Candidate Background and Qualifications

• Ideal Background: Process development for biologics, specifically for therapeutics that have gone into clinical trials or are approved drugs.
• Required Technical Skills: Downstream bioprocessing, normal flow filtration (NFF), tangential flow filtration (TFF), and chromatography.
• Regulatory Knowledge: General understanding of developing a drug manufacturing process under FDA and EU Medical (EMEA) regulations.
• Soft Skills: Must be self-motivated, organized, and able to work independently.
• Additional Knowledge: Knowledge of GMP practices and familiarity with analytical assays.

Preferred Skills (Stand-out Qualities)

• Experience writing to support IND (Investigational New Drug) or BLA (Biologics License Application) filings.
• Design of experiment and statistical analysis skills using JMP.
• Direct experience with process characterization.
• Experience with both early and late-phase clinical trial development.