Sr. Associate Scientist-61355-1
Hybrid · Summit, New Jersey, United States
Job Summary
Senior Scientist of Biostatistics within the MSAT team at Summit, NJ, focusing on CPV and APQR for personalized cell therapy products. Responsibilities include monitoring/trending CPV parameters, MSPA/Quality Control Release attributes, SPC program maintenance, multivariate analysis/modeling for process understanding, alerting stakeholders to drifts, supporting CPV/APQR investigations and regulatory readiness, cross-functional collaboration with Supply Chain, Manufacturing, QA, and Engineering, and ensuring cGMP compliance in a 24x7 manufacturing environment.
Required Qualifications
- Bachelor’s Degree required (science or engineering preferred); Graduate or higher-level Degree preferred
- 8 or more years of work experience in the biopharmaceutical or related industry
- 8 or more years of manufacturing support or related experience in the biopharmaceutical industry
- Experience in CPV and/or APQR reporting preferred. May be substituted for relevant experience in monitoring/trending performance of Quality attributes
- Experience in cell therapy, biologics, or vaccine manufacturing/support required
- Experience with Operational Excellence and Lean Manufacturing is a plus
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