The successful candidate will apply scientific and engineering principles to support new biopharmaceutical process enrollments into the cGMP manufacturing facility. The candidate will:
- Collaborate with process development and manufacturing teams to perform technical transfer and facility fit activities for downstream processes.
- Perform all aspects of facility fit activities to support program enrollment including generating process flow diagrams, bill of materials (BOM), new specifications, and Äkta chromatography methods.
- Perform batch record, solution record and deviation reviews.
- Lead technical deviation investigations and collaborate with Operations, process development and Quality teams to determine the impact, root cause, and corrective actions for the deviation.
- Identify and support implementation of new equipment (IQ, OQ, and PQ).
- Provide on-the-floor technical oversight and client escort as required during cGMP manufacturing runs.
- Author technical documents including deviations and campaign summary reports.
- Compile, analyze, and present manufacturing process data to internal and external program teams.
- Identify process and facility improvement projects and independently drive projects to completion.
- BS/BA in Science or Engineering with 1-5 years Biotechnology experience or Masters with 0-3 years industry experience. Ideal candidate will have broad based knowledge of upstream and/or downstream processing techniques and equipment.
- Experience with technical transfer is desired.
- Experience working in a cGMP manufacturing environment is 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.