Job Summary:

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.

Qualifications:

• 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.