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.
- 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.
KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its work force. Therefore, all qualified applicants, regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability or Vietnam veteran status, are strongly encouraged to apply.