Job Summary:

KBI Biopharma, Inc. is a contract services organization committed to reducing process development time, decreasing production cost and increasing speed of development for biopharmaceuticals. We are seeking an In-Process Support Associate with strong protein chemistry background to perform cGMP in-process analytical support. These services include in-process and release testing for drug substances manufactured internally.

Job Description:

• Execute activities according to cGMP regulations and company SOPs.
• Provide STAT assay coverage including 2nd shift and weekends as required by the manufacturing schedule.  Assays include A280 and RP titer.
• Log samples or verify sample log in outside of standard business hours.
• Review peer’s data for compliance and accuracy.
• Execute other analytical assays as required by the batch records.  Assays may include SEC, IEX, Appearance, pH etc.
• Report STAT results to manufacturing to allow for forward processing.

• BS in scientific discipline or equivalent with a minimum of 0-2 years’ experience in QC analysis of proteins, antibodies, peptides, or vaccines.
• Excellent verbal and written communication skills.
• Experience working in a cGMP environment preferred.